Analytical Chemistry Expert (19-00914) – TX – Fort Worth

Duties:

Design and execute method development for small molecule drug substances and drug products
Execute Novartis protocols for analytical method validation
Execute routine and non-routine analytical testing using a variety of modern techniques such as HPLC, GC, LC/MS, FTIR, and XRPD
Use modern software and LIMS systems
Compile, analyze, and present data
Author technical documents
Assist with OOE and/or OOS observations
Participate in project team meetings as required

Education and Required skills:
Chemistry degree (BS, MS, Ph.D.)

Experience in a regulatedPharmaceutical (GxP) laboratory environment
Expertise in small molecule characterization
Experience with solution, suspension, and emulsion dosage forms
Significant experience with analytical method development and validation in accordance with ICH guidelines
Mass spectrometry experience and thorough understanding of organic chemistry is a plus

 
Source: Job Diva – Job Listing

Senior Researcher (19-00913) – MA – Cambridge

Description:
We are seeking an experienced and highly motivated research scientist who will work to assist scientists in the group with the development of in vitro and in vivo based assays focused on cell signaling, cell function and biochemistry. 
The successful candidate will be proficient in utilizing his/her experience in molecular and cellular biology techniques to support project objectives.
 
Duties:
– Dosing, perfusion and collection of mouse tissue and fluids. 
– Isolation and maintenance of murine cells from the brain and other organs. 
– Mammalian tissue culture. 
– Using imaging and flow cytometry plate-based assays to determine effect of lead compounds on cellular function. 
– Examination of protein expression, modification, and secretion using flow cytometry, ELISA and western blotting. 
– An organized approach to stringent data analysis and the maintenance of an Electronic Laboratory Notebook. 

 
Required:
The candidate should be experienced in primary cell culture and be familiar with processing cell samples for downstream assays.
They should have strong flow cytometry experience and experience with techniques such as ELISA and western blotting.
An understanding of CNS cell-based assay development is a benefit.
Significant understanding of basic neurobiology of neurodegenerative diseases and mechanisms of neurodegeneration is preferred.
Experience with in vivo disease models is a plus.
The ideal candidate should be well organized, possess excellent technical and communication skills, as well as the ability to work collaboratively in a team environment.
Flexibility and willingness to learn and master new techniques are highly valued.
We seek a creative and diligent person who brings care and attention to detail to the job. 
BS/MS in biological sciences with 3-4 years relevant experience in academia or industry.

 
Source: Job Diva – Job Listing

OIM support analyst (19-00910) – PA – Chesterbrook

Experience with supporting OIM/OAM 11gR2PS3
Experience with Linux based OIG platforms
worked with OOTB AD, Flat file, servicenow, webservice and database connectors
Good understanding of OIM database schema, how to use SQL tools and generating business significant reports
Experience writing and using java clients for adhoc bulk OIM operations
comfortable providing outage support at critical times and executing root cause analysis post remediation
Experienced with performing initial analysis and proposing resolution on issues and requests
knowledge of how to get and evaluate thread dumps
can differentiate between one off issues and platform issues, comfortable bringing up recurring and platform issues to management
able to follow deployment instructions to make configuration changes, deploy new connectors/event handlers/ process task adapters, regular system maintenance patching
BiPublisher knowledge is a plus
CA APM Experience is a plus

 

Source: Job Diva – Job Listing

Scientist, QC Investigations (19-00909) – NJ – Morris Plains

Duties:
Lead and perform QC deviation investigations to adequately identify root cause and assign appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence to support QC department operations
Lead and perform out-of-specification (OOS)/out-of-expectation (OOE)/out-of-trend (OOT) investigations to support QC department operations
Employ standardized root cause analysis, investigation tools and methodologies
Utilize Quality Management Systems such as Trackwise for owning QC investigations and tracking statuses
Train on Bioanalytics, Microbiology, and Raw Material test methods to build a knowledge base to support compliance-related activities
Participates in cross-functional teams for 5S/lean lab projects and continuous improvement programs to maximize efficiency
Participate in internal and external GMP and HSE audits
Timely delivery on commitments and departmental KPIs.
Ensure adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations
Other duties as assigned

To support both domestic and international activities, working off shift or weekends may be necessary on short notice
Minimum 5 years of relevant experience in pharmaceuticals, biologics, microbiology, or aseptic manufacturing
Previous experience in execution of OOS/OOE/OOT investigations and deviations
Knowledgeable in FDA/EMA/JP guidelines and cGMP requirements
Knowledge and familiarity of LabWare LIMS and/or other QC data systems
Knowledge of Quality Management Systems, such as Trackwise, ESOPS, and Subway
Proficient using Microsoft Office (Word, Excel, PowerPoint, Project)
Detail-oriented with expertise in problem solving and solid decision making abilities
Strong written and verbal communication skills are essential
To support both domestic and international activities, working off shift or weekends may be necessary on short notice
May use a computer for extended periods
Must be proactive, responsive, and able to work independently
Strong analysis and decision making skills surrounding documentation
Source: Job Diva – Job Listing

Quality Control Technician I (19-00908) – TX – Fort Worth

NOTE: This position is 2nd shift including one weekend day. Initial training may take place on 1st shift depending on scheduling.
Provide support for QC Chemistry analytical prelim, finished product, and stability testing.
Perform laboratory activities to support product testing.
Review laboratory data.

The ability to work independently following an approved protocol.
The ability to function in a team environment.
The flexibility to work overtime as required by the aggressive project schedule.
Good technical writing skills and the ability to communicate technical issues to project lead and team.
Source: Job Diva – Job Listing

Regulatory Affairs Specialist I – CMC / Medical Devices (19-00907) – MA – Cambridge

Duties: 
This position will primarily provide regulatory submission process support for Company’s Global Regulatory Affairs (GRA) Devices team, which has responsibility for diagnostics, medical devices and combination products.  This position will interface with regulatory affairs colleagues' world-wide, as well as global research and industrial affairs functions.  The primary scope of activities for this role will be the development, optimization and implementation of regulatory device processes. 

Major Activities/Key Responsibilities:

GRA Device Portfolio Management
 – Building and maintain a tracking system for the complete GRA Device portfolio  – Liaise with cross-functional portfolio teams to identify programs which require GRA Device support, evaluate stage of program and scope of activities required  – Facilitate resource nomination to support the incoming programs  – Maintain the GRA focal point listing with GRA Device representatives

Submission Templates
 – Optimize Company-specific instructions for medical device submission and health authority interaction templates, building on historical experience from prior submissions
 – Develop/optimize CTD template structure and baseline content specific for the delivery device technologies in the Company portfolio (pen injector, autoinjector, large volume device, syringes) for investigational and registration submissions, building on historical experience from prior submissions
 – Lead cross-functional review of these submission template drafts and actively drive the activities to implement the final templates within the document management systems

Device Submission Publishing and Archival Processes
 – Liaise with Global Regulatory Operations to develop processes to support publishing and archival of medical device submission documents, leveraging prior experience managing these submissions

Process and Procedure Development
 – Learn the roles and responsibilities for GRA devices across the various device types (combination product, diagnostics, digital, consumer health, biosurgery)
 – Perform gap analysis of existing procedures to identify areas where improvements can be made to optimize the procedures to account for the GRA device roles and responsibilities
 – Contribute to the design, optimization and implementation of device-related Company Regulatory processes and procedures
 – Participate in the development and optimization of processes and procedures relevant to submissions, representing the device-specific aspects

Skills: 
Knowledge of relevant medical device regulations (FDA, EU, HC, etc.)
Familiarity with the biopharmaceutical development processes
Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Excellent in English language, including technical and regulatory writing skills
Proficient in MS Word, Excel, PowerPoint
Experienced in regulatory submission authoring with a clear understanding of eCTD structure and technical writing standards and approaches
Comfort with electronic document management systems and authoring tools
Excellent organizational and communication (written and verbal) skills.
Demonstrated attention to detail and problem-solving abilities
Demonstrated ability to work successfully on project teams.
Able to work independently to drive results

Education:
University science degree, with 2 – 4 years of CMC or medical device regulatory experience
 
Source: Job Diva – Job Listing

Regulatory Affairs Specialist III — CMC (19-00906) – PA – Swiftwater

Candidate to author/review/approve CMC technical documents in internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities. Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC. Provide regulatory guidance for development projects, post-approval CMC changes/variations. Must have working knowledge of GMPs. Must be well-organized, work with minimal management and meet aggressive timelines. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality. **This position is working in the CMC area. Relevant experience is required
Experience with drug/biologics licensure
Prior regulatory experience
Technical writing experience (CMC experience )
Scientific background

CMC/ Regulatory writing experience – 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3
Scientific background, vaccines preferred
Microsoft Office (word, excel, powerpoint)
Documentum/ Veeva Applications
Trackwise Applications
ICH Guidelines
GMP experience
Experience with drug/biologics licensure preferred
Prior regulatory experience
Source: Job Diva – Job Listing

3rd shift QA Analyst (19-00905) – TX – Fort Worth

-To perform activities that ensure required quality and safety standards are being met for our products.
-Audit product lots , Pull analytical samples, Pull, log, and inspect retention samples.
-Review MBR (Manufacturing Batch Record) for release.
-Review and approve autoclave charts, log books, and MBRs.
-Print supplemental paperwork and issue to MBR.
-Verify variable coating prior to initiating production and/or for in-process changes.
-Work in inventory systems, release systems, laboratory management systems, databases and Approve for further processing.
-Cooperate and support coworkers to enhance overall capability of the organization.
-Participates in problem solving and troubleshooting of issues.
-Coordinate/support other departments to ensure smooth execution of work. Communicate effectively with production, maintenance, warehouse, and other functions as necessary

-Ability to use Microsoft applications.
-Ability to work off shift – 12 hour shifts – includes some weekends
Source: Job Diva – Job Listing

Recruiter I (19-00904) – CA – San Diego

Duties:

The Recruiter, Talent Acquisition, will manage the full recruiting life cycle to drive best in class recruiting practices and strategies. The Recruiter must be able to design and implement various recruiting strategies, be an independent self-starter with full lifecycle experience handling diverse client groups, and have the ability to understand and utilize recruiting metrics. The Recruiter will closely collaborate with the Talent Acquisition Director in leading strategic project efforts, driving recruitment sourcing strategies, recruiting for diverse functions and roles, managing external recruiting partners, supporting branding/outreach recruitment efforts, ensuring ROI on recruitment tools/partnerships. Essential Duties & Responsibilities: • As a member of the Talent Acquisition team, you will lead full life cycle recruiting including creative sourcing solutions to identify, attract, and hire best in class talent in a timely and cost effective manner primarily for Headquarters (Parsippany) and the Science Center Campus (San Diego) • Coordinate intake calls with assigned hiring managers to determine talent acquisition solutions best aligned to business needs, and to broaden understanding of scope of position requirements • Partner closely with key stakeholders including HR colleagues, talent acquisition team, department administrative support, and external vendors throughout the candidate selection process, and have the ability to identify when to escalate candidate/requisition issues • Utilize and maintain applicant tracking system and act as an SME • Ability to understand and support recruitment reporting needs and operate within the measurements and standards that are set forth • Support project needs and strategies to drive best in class TA operations • Act as a brand ambassador and promote the Pacira employer of choice brand consistently and ensure brand messaging is consistent across all channels • Ensure that hiring manager and candidate experience is exceptional by providing consistent communication via phone or email • Drive multiple candidate channels including referrals, social media platforms, and other campaigns as needed • Continually build and maintain networking relationships with a focus on broadening and increasing our talent community and presence in the market • Communicate with managers and employees regularly to establish relationship and source new candidate leads. • Be aware of and informed on all compliance/ EEO related standards, and applicable federal and state laws as directed accordingly

Skills:

• Minimum 5 years full life cycle recruiting experience, preferably in a corporate setting. Pharmaceutical or Biotech strongly preferred. • Demonstrates knowledge of corporate business operations and the ability to translate business needs into recruitment strategies and actions • Demonstrates understanding of compensation principles and must possess the ability to make thoughtful and data driven offer recommendations • Ability to track and implement recruitment metrics • Must have prior ATS experience, Cornerstone preferred. • Demonstrated expertise in utilizing progressive sourcing options such as direct sourcing, Web 2.0 recruitment tools, networking, employee referrals, college and diversity recruitment • Familiarity with behavioral interviewing techniques (Targeted Selection) • Excellent customer service ability; utilizes a highly consultative approach when collaborating with internal and external clients • Strong verbal, written and presentation skills and demonstrated strong negotiation and influencing skills • Strong communication and relationship management skills
Source: Job Diva – Job Listing

Oracle Exadata DBA (19-00903) – PA – King of Prussia

Senior Systems Engineer / Oracle Exadata DBA who will be responsible for providing technical support to the organization’s internal users of computer applications and hardware (e.g., Exadata database appliance, and VM servers running Oracle/SQL database).

Our ideal candidate is a strong Oracle Exadata DBA with Oracle 11g/12c/18c/19c, Oracle RAC, Oracle GoldenGate, Oracle Data Guard/Active Data Guard experience, and some hands-on experience supporting MS SQL Server databases (2008, 2012, 2014, 2016, 2017) is preferred.

To be successful in this role, you will need to have good experience and knowledge in troubleshooting and performance tuning, and strong communication and team work skills. The DBA will be part of global on-call support. Some hands on experience supporting MS SQL Server databases (2008, 2012, 2014, 2016, 2017) is preferred.

Key Responsibilities:
Manage Oracle Exadata environment, coordinate with Platinum support, coordinate with application owners on patching activities, cohesively and collaboratively work with peers, help develop standardization and process improvement.
Collaborates with network services, software systems engineering and/or application development in order to restore service and/or identify problems.
Manages database utilities, monitors the relationships between the database users and applications, and maintains the organization’s databases across multiple platforms and computing environments.
Maintains database support tools, database tables and dictionaries, recovery and backup procedures including Disaster recovery testing.
Help in investigating and troubleshooting issues to identify root cause, representing database team on outage calls, answering questions regarding database system procedures, systems status and downtime procedures.

Qualifications:
Required Skills & Experience:
12+ years of related experience working with integrated enterprise systems
4+ years of production hands on working and supporting experience in Oracle Exadata.
Oracle DB (10g, 11g, 12c) primarily on Oracle Exadata, RHEL Linux and few on Windows
Coordinating with Oracle platinum support for Exadata support and patching.
Oracle RAC, Data Guard, Active Data Guard, Golden Gate
Microsoft SQL (2008, 2012, 2014, 2016, 2017)

Technical Knowledge and Skills:

Database migrations and upgrades
Database Patching and Compliance
Windows Clustering, Log Shipping, SQL Always On
Database schema creation and management
Database backup and recovery
Disaster Recovery
Ensuring data integrity and availability
Performance management, tuning, tracking
Capacity planning and reporting
Database management, monitoring and maintenance
Database licensing and security
Database health, integrity and space.
Bachelor’s Degree or equivalent experience, (Technician Degree CCI required for Germany); educational concentration in a computer-based discipline (e.g. Computer Science, Information Systems) or a technical discipline (e.g. Engineering, Mathematics) is preferred.
Preferred Skills & Experience (not required):
Pharma/Biotech or similarly regulated environment experience preferred.
Oracle Exadata experience is required.
Oracle DBA and (MS) SQL certifications preferred.

Source: Job Diva – Job Listing

IAM Developer (19-00902) – PA – King of PRussia

The Sr. Application Developer is responsible for delivering high quality technical solutions in support of SailPoint IIQ. Ability to translate SailPoint requirements into coding and configuration solutions.  Responsible for creating and maintaining the relevant identity and access management system configurations:  SailPoint IdentityIQ and SailPoint IdentityNow/Ping. The Developer participates in all aspects of software life cycle development, designing and maintaining SailPoint solutions 
 

  • MUST HAVE:  2+ years as identity and access management experience with SailPoint IdentityIQ v7.2+
  • Languages: Java / J2EE programming experience in designing, coding, testing and implementing on SailPoint IIQ v7.2+
  • Understanding of ISO 2700X series security standards

Pharma/Biotech or similarly regulated environment experience preferred.
 

Demonstrated knowledge of the following required:

  • Special Technologies: Experience with Rest Web services, SAML 2.0, Sailpoint IIQ and IdentityNow/Ping, OAuth, WS-Security, Public Key Infrastructure (PKI) and other authentication/authorization protocols is preferred.
  • Software Packages: SailPoint IIQ, SailPoint IdentityNow/Ping, SailPoint Security IQ
  • Certifications: IT Security Industry certifications (CISM, CISSP, CISA, etc) is a plus
  • Strong software development and design skills using integration technology
  • Computer literacy with Microsoft Office products, such as Project, PowerPoint, SharePoint, Excel, and Visio.
  • Experience in supporting IAM and SSO architectures

Source: Job Diva – Job Listing

Clarity Tester (19-00901) – PA – King of Prussia

Experience/Skill: 

  • 6+  years of experience in the field of testing and Quality Assurance   
  • Experience using test management tool, Client ALM and GxP validation approval workflows (either paper or electronic)
  • Experience as a tester or test lead in field of Program Portfolio Management (PPM). Specific experience in CA Clarity is desirable.
  • Experience with system/functional testing, integrations testing, data migration testing and UAT coordination. Experience in test script creation and testing in a validated environment.

 
Responsibilities:

  • Analyze user requirements and functional specification for the project and identify testing scope
  • Based on testing scope, create an estimate of testing activities and create a testing schedule
  • Come up with a testing approach and strategy for the project and create test plan per CSL BT process
  • Coordinate with project team (including business) to identify key functional test scenarios and UAT test scenarios
  • Create test scripts, upload in QC Vera (Client ALM) system, review with Validation team (BT Quality) and receive approval of scripts
  • Create test execution plan, resource assignments, test lab setup in QC vera and communications
  • Coordinate with project team to ensure test data setup and testing resources are lined up for test execution
  • Execute test scripts, resolve issues faced during execution, coordinate test script approvals and perform defect triaging
  • Ensure timely delivery of all testing deliverables and raise risks and issues to management in a timely manner.
  • Create test summary report providing details of testing activities performed in the project
  • Provide weekly status report to CSL for testing, daily status reports during test execution, capture and report testing metrics and manage change requests per CSL process

 
 

Source: Job Diva – Job Listing

Administrative Assistant II – Medical Affairs (19-00898) – WA – Bothell

Description:

Position Summary
As an Administrative team, we are a group of individuals that love what we do and enjoy the people we work with. We know that the relationships we build are genuine and positively contributes to our work environment. We are intentional in cultivating a culture that is inclusive, collaborative, and celebrates our individual initiatives.
To be successful in this role you’ll need to be flexible, self-motivated, detail-oriented, and provide exceptional support to the Medical Affairs leadership team and to the senior administrative assistants within the Medical Affairs organization. You’ll be a positive and professional role model in the organization and possess strong decision-making skills, be forward-thinking, collaborative, and have a reputation for problem-solving and troubleshooting in an evolving business environment.

Principal Responsibilities
• Primary support to the Medical Affairs leadership team and Bothell-based team. Responsible for maintaining the rhythm of the business through proactive planning and execution of administrative support to ensure a seamless experience for leadership and team
• Primary backup support for the Sr. Administrative Assistant to the VP, Medical Affairs and to the Sr. Administrative Assistant for MSLs/field-based staff
• Manage and maintain calendars on a daily, monthly, quarterly, and annual basis to ensure accurate scheduling and prioritization.
• Organize complex and extensive domestic and international travel, which requires assembling travel packets and arranging all travel logistics
• Track department budgets and expenses in compliance with company policy; review and approve invoices and account reconciliation. Also includes timely preparation of expense reports
• Adhere to and execute administrative procedures for the team staying within corporate policy
• Responsible for flawless planning and execution of onsite and offsite meetings, events, and conferences
• Assist the team with catering, AV, IT and other set ups for internal and external meetings, including the teams’ participation in multiple conference, congresses, and workshops
• Assist employees with conference registration and help maintain professional memberships, contact databases, and group rosters for subscriptions
• Ensure a positive employee experience through the successful onboarding of new hires by making sure all necessary documents and office equipment are in place
• Backup support for other admins within team
• Assist with other projects and work as needed and assigned
• Collaborate with other administrative staff to support department and/or company-wide events and various other initiatives as needed

Qualifications
• 2 – 4 years in an administrative role supporting senior management in a fast-paced, technology-driven environment
• Some college coursework preferred
• Demonstrated experience supporting a growing team that is multi-located
• Ability to apply knowledge of the business and integrate into daily tasks to achieve successful outcomes in cross-functional projects and activities
• Excellent organizational and interpersonal skills are required
• Ability to prioritize work and deliver projects completed and on time while facing multiple distractions and interruptions
• Demonstrates and role models confidence, emotional intelligence, and professionalism
• Ability to pay close attention to detail when working with complex schedules or projects and react with an appropriate sense of urgency to situations or events that require a quick response or turnaround
• Ability to independently problem-solve to quickly resolve issues to maintain business continuity
• The ability to maintain a positive attitude with the ability to adapt quickly to changing priorities; must work well under pressure
• The desire to learn and grow with the business
• Able to work successfully in a team environment by building effective working relationships internally and externally with all levels of employees with different working styles and perspectives
• Promote the Mission, Vision and Values of *** in all areas of responsibility
• May require travel up to 2-4 times per year for company events and various projects
• Highly proficient in MS Office products (Outlook, Word, Excel, and PowerPoint)
Source: Job Diva – Job Listing

Research Associate I Continuous Manufacturing (19-00897) – MA – Framingham

Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision. Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters. Experience: 0 to 3 years.

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Source: Job Diva – Job Listing

Manufacturing Tech II (19-00893) – PA – Exton

Responsibilities include manufactuing products efficiently, accurately, safely and on-time, utilizing manufacturing equipment and in-process instruments in accordance with Current Good Manufacturing Processes (cGMPs), company policy, and Environmental Health & Safety (EH&S) requirements. Operate and monitor, and control a batch process to produce output to production schedule and to meet product specification in two process areas: (Dispensing, Fluid Air, NIRO Granulation, Compression, Coating, Printing, Encapsulation). Perform math calculations required for batch processing: such as determining loss amounts, process yields and accountability and verifying inventory reconciliations. Resolve complex manufacturing issues utilizing expert knowledge. Participate in Factory Acceptance Test (FATs) as requested to ensure integrity and full functionality of equipment in preparation for validation. Actively participate in-process improvment (Lean Six Sigma) initiative which may include serving as the subject matter expert. Noise level is moderate-to-loud. Must be able to lift up to 50 lbs as required. Ability to work in a team environment. High School or GED Required, but Associates Degree Preferred. General knowledge of MS Windows (e.g. Word), Lotus Notes, eLLIE, Documentum (SOP Reading, Training Requirements), SAP, HMI (Screen Navigator). GMP, Process Improvement, EH&S safety certifications. Bioworks certificate preferred. 3-5 years experience with pharmaceutical manufacturing experience or biotechnology experience preferred.
Source: Job Diva – Job Listing