Compounding Assistant – 3rd Shift (19-00750) – TX – Fort Worth

Duties: Working under the direction of the Production Manager or Supervisor, the incumbent is responsible for supporting the production of quality sterile filtered products to meet the production schedule, which includes cleaning and preparation of processing equipment, maintaining the inventory of supplies and general housekeeping duties. Responsibilities include integrity testing of filters, preparation and sterilization of processing equipment, and coordinating task and schedules within the group and across functional lines. Due to business needs, it may be necessary to work overtime including nights and/or weekends
Skills: Skills include high degree of technical/mechanical aptitude: ability to function in a team environment; ability to operate computerized equipment; ability to function in a fast-paced machine paced environment; excellent interpersonal skill; and the ability to learn aseptic compounding procedures.

Must haves:
Ability to work 3rd Shift 2300-0730 (Tue-Sat)

Must haves:
Ability to follow rules continuously
Very close attention to details
Eager Learner
Ability to manage time well
Ability to work under pressure
Completes the job correctly not just quickly
MUST be able to prioritize tasks and make sound judgment calls
Selft motivated – interested in a growing their career (starting from the middle and working their way up)
*Computer Proficient*

Keywords:
Education: Would like – (30) hours of college credits including two chemistry courses with laboratory (8 hours), and two or more years of external pharmaceutical (manufacturing industry) processing experience (water systems, sanitization, sterilizer, technician), or six months internal  related manufacturing experience. Skills include high degree of mechanical aptitude; ability to function in a team environment; ability to operate computerized equipment; ability to function in a fast-paced machine-paced environment; excellent interpersonal skills; and ability to learn aseptic compounding procedures.

Would like – Bachelor's degree in Science or Engineering and Chemical Compounding Experience.
Skills and Experience:
Required Skills:
ASEPTIC
CHEMISTRY
COMPOUNDING
HOUSEKEEPING
INVENTORY
Additional Skills:
LABORATORY
MANUFACTURING INDUSTRY
MECHANICAL APTITUDE
PROCESSING EXPERIENCE
SANITIZATION
STERILIZATION
WATER SYSTEMS
PRODUCTION SCHEDULE
STERILE

Source: Job Diva – Job Listing

Sr QC Analyst (19-00749) – TX – Fort Worth

Duties: Senior Quality Control Analysts have the following responsibilities:

Perform laboratory activities to support method validation.
Write method validation protocols and reports.
Generate and revise analytical test procedures.

Senior Quality Control Analysts should have the following skill set:

Familiar with current Good Manufacturing Practices and Good Lab Practices.
Familiar with current ICH and USP guidance for analytical method validation.
Familiar with analytical lab equipment and analytical lab techniques (e.g. HPLC, TLC, UV)
The ability to work independently following an approved protocol.
The ability to function in a team environment.
The flexibility to work overtime as required.
The ability to demonstrate creative and innovative thinking to solve analytical problems.
Good technical writing skills and the ability to communicate technical issues to project lead and team.

Skills: Minimum Qualifications:
Bachelors of Science degree in Chemistry or other science
5 years of analytical laboratory experience
3 years analytical method validation experience
Proficient in MS Word and Excel.

Preferred Qualifications:
3 years of experience in a Pharmaceutical manufacturing facility
7 years of analytical laboratory experience
5 years analytical method validation experience
Keywords:
Education: Bachelors of Science degree in Chemistry or other science

Source: Job Diva – Job Listing

Quality Auditor (19-00748) – AZ – Tucson

Responsibilities

Performs business quality system audits – includes audit preparation, conducting audits, writing audit reports, communicating findings to suppliers, business, and stakeholders, and audit follow-up.
Continuously improves the effectiveness of existing quality systems and processes by converting quality system related deficiencies identified through audit findings into improved system and process practices.
Reviews and approves corrective action plans and actions as a result of audit findings.
Effectively executes and/or follows-up on CAPA (Corrective and Preventive Action) Quality System non-conformance or improvements. Performs all activities in full compliance with the quality policies and procedures.
Makes decisions with some level of oversight.
Verifies closure of corrective actions and preventive actions from audits. 
Determines statistical sampling of documents and records to be reviewed during audits.
Prepares audit trend reports.
Supports sites, affiliates, departments, and areas across the client to sustain compliance against applicable standards and regulations.

MUST HAVES:

  1. ISO-13485:2016, MDSAO 2016, FDA certified
  2. ASQ Bio Medical Certification
  3. Heavy on Process audits
  4. SAO/ERP ( ETQ)

 
 
Source: Job Diva – Job Listing

Senior Medical Data Scientist (19-00745) – NJ – Woodcliff Lake

Sr. Medical Data Scientist (Sr. CODER)

Must have at least 10 years of assigning standard terminologies within Clinical Research, familiar with protocol and CRF designs. Adequate knowledge of ICH guidelines.

Ensures verbatim /reported terms are adequately reported and able to assign MedDRA or WHODD terms. Responsible for resolution of PT in SAE reconciliation in collaboration with PDM and PV. Post queries for relevant information. May require to put together search groupings.

Quantitative analysis – Performs a coding and review coding listing from first pass coder in preparation for Study director/Clinical Team review and approval.

Qualitative analysis – Ensures all relevant information is captured in clinical database and provides quality. Ability to evaluate search groupings and perform justification of definition.

Performs all duties according to company policy and regulations and guidance. Performs other duties assigned by the Director or Sr. Manager. No travel required.

QUALIFICATIONS:
– Graduate of adequate health care related course and familiarity with medical terminologies.
– Minimum of 10 years Coding experience within Clinical Research.
– Strong knowledge of ICH guideline
– Knowledge of CODING SYSTEMS, INFORM, J -review is a plus and/or other Clinical trial Systems
– Proficiency on all related regulations, GCP, and Good Clinical DM Practice
– Computer proficiency
– Expertise on use of Microsoft applications, e.g word document, power point, excel
– Strong oral and written communication skills
Source: Job Diva – Job Listing

Quality Engineer – QC Labs (19-00744) – TX – Fort Worth

Duties: Provides mentoring, assistance, support and oversight to Quality Control Laboratories related to validation and qualification change control, calibration, preventive maintenance, root cause investigations and investigation tools, corrective and preventive actions, general process challenges and troubleshooting, as well as execution of risk management processes (risk identification, mitigation, and controls) in compliance with external standards and corporate requirements.

Provide direction and quality oversight in the development, maintenance, and compliance of Quality Systems directly related to Quality Control Laboratory operations.
Lead the quality oversight of larger-scope and more technically complex non-conformance investigations and implementation of corrective and preventive actions.
Perform evaluations of process quality and performance attributes to identify continuous improvement initiatives related to Quality Systems and process control infrastructure to ensure continued sustainability of manufacturing operations and products.
Actively participate in and contribute to routine engineering and manufacturing-based meetings, including presentation of metrics, process challenges, Quality-related initiatives, etc.
Provide a source of consistent quality oversite to engineering lifecycle and change control. This includes; proper matrixed validation approach, attribute inspections, exception handling, proper order of operations, timely closure, appropriate validation paths, reviews of holistic validation packages.
PPC (Product or Process Change)
URS/FRS (User Requirement Specification/Functional Requirement Specification)
SDD (Software Design Document)
ECO (Engineering Change Order)
FAT (Factory Acceptance Test)
Project VMPs (Validation Master Plan)
TMD (Traceability Matrix)
IOQ (Installation Operation Qualification)
PQ (Performance Qualification)

Ensure consistent application of GDP and DI on all documentation.
Provides Quality representation and approvals at the Change Control Board for change requests within respective product areas.
Participate in efforts to streamline change control and Automation Lifecycle Management processes.
Initiate Engineering Change Control (ECO) and Product Process Change (PPC) documentation
Assure adequate product and process controls are in place for identified CTQs. Uses various statistical and non-statistical problem-solving tools as part of analysis.

Skills: Minimum Education / Experience:

Bachelor’s Degree in a scientific technical discipline (preferably engineering, chemistry or microbiology) 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, computerized system knowledge, product and process validation, trending, and change control
Microsoft Office Suite with advanced Excel charting experience and statistical analysis capability
Proven problem solving skills, and ability to meet deadlines under pressure
Well organized, with good time-management skills, ability to build rapport

Desired Experience:

Technical understanding of aseptic process or QC laboratory process
Quality Lab Experience
Strong GMP Documentation Skills
Above average understanding of Manufacturing / Production Principles
Strong computer skills, including Microsoft Word, Excel, Power Point, and Project
Excellent organizational skills

Ability to manage multiple priorities
Previous experience with FT-IR, HIAC, microscopic examination, LIMS and track wise preferred.

Keywords:
Education:
Bachelor’s Degree in a scientific technical discipline (preferably engineering, chemistry or microbiology) 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, computerized system knowledge, product and process validation, trending, and change control

Source: Job Diva – Job Listing

Laboratory Technician II : Purification Process Development (19-00743) – MA – Framingham

Duties:
Join a team dedicated to supporting purification development and other activities within Bioprocess Development, Biologics Development.

Responsibilities:
– Work independently under general supervision and direction. Work is reviewed for overall adequacy and accuracy.
– Operate complex lab equipment and execute experiments as per written or verbal instructions.
– Prepare buffer solutions or chemicals as needed.
– Prepare and sterilize laboratory equipment for operation.
– May involve work with hazardous materials. On the job training will be provided.
– Progress to performing independent experiments and studies.

A general knowledge of laboratory procedures, purification equipment, and terminology. Should be able handle multiple tasks simultaneously. Able to carry out tasks according to verbal and written instructions. Demonstrated interpersonal skills and effective communication skills required. Demonstrated ability to operate and care for laboratory equipment. Requires physical demands of lifting up to 20-25 pounds.

Education:
Requires a minimum BS degree with 3-6 years of experience in a scientific laboratory setting or MS degree.
Source: Job Diva – Job Listing

Business Systems Analyst III (19-00742) – CA – South San Francisco

As IT Product Manager you will oversee one or multiple products (technology or data solutions) within a Network’s mandate being accountable for the end-to-end product lifecycle and ensuring, in partnering with relevant business stakeholders, that the products are fit-for-purpose.
What you’ll be working on
Co-create product vision and strategy with business partners (e.g. Business Process Owner/Manager, Product Owners) in collaboration with IT experts (e.g. Architects and Business Analysts), external vendors and brings in a value adding Informatics point of view to help continuously improve business processes and solutions. Manage the long-term product roadmap.
Smell opportunities to create additional value and improve business processes and patient outcomes
Manage product lifecycle including release management and decide when enough value has been accrued to warrant a release to the business. In collaboration with Product owners, prioritize product releases considering the optimal flow of throughput from different teams/squads
Determine business criticality and product quality. Define, in collaboration with Delivery Service Manager, service levels, governance and operational support
Lead or coordinate technical discussions and vendor negotiations
Support C-Pod in prioritization and strategic planning, and collaborate with IT Business Partners to meet the needs of the business areas they are partnering with
In collaboration with IT Business Partners, monitor and improve customer and user experience
tifacts into an electronic format and provide input in design sessions
¿ Contribute in roadmap discussions and vendor assessments
¿ Clear communicate keeping IT and the customer apprised of developments and requirements, key metrics
¿ Collaborate with IT Project Managers and the customer. Must build strong relationships with our customers
¿ Analyze and document current and future business process models
¿ Analyze and document requirements (scope), business rules (use cases)
¿ Analyze and document data requirements (from business needs perspective)
¿ Plan user acceptance test (UAT), create UAT scripts and facilitate UAT
¿ Collaborate with customers, IT project managers, Architects, Developers & Software Quality Assurance on solutions and risks
¿ Mentor the teams on UX best practices and oversee the creation of delightful prototypes & dashboards
¿ Perform knowledge transfer to training and communication teams
¿ Support user deployment activities as needed
Lead stakeholders thru the business analysis lifecycle

The ideal candidate
Knows Javascript (must), knows Quickbase and Veeva (desirable)
Has business domain knowledge for the following area(s): Pharma, Biotech
Exhibits the behaviors of a Lean-Agile Leader with a Lean-Agile Mindset
Exhibits intellectual curiosity and integrity and has strong passion to bring value-adding technology to the business.
Entrepreneurial mindset
Source: Job Diva – Job Listing

Medical Reviewer, Pharmacovigilance (19-00741) – NJ – Woodcliff Lake

Job Description
• Provides medical expertise in the review and evaluation of safety information for investigational and marketed products, including evaluation of serious clinical trial adverse events and spontaneous reports of adverse events
• Assesses the relationship between drugs and adverse events
• Evaluates case reportability per local regulatory requirements and meets appropriate timelines for case review
• Participates in the training of the Safety Specialist and Coordinators

Essential Functions
Responsibilities Percent of Time
1. Medical Review of Individual Safety Case Reports: 93%
2. Participates in the training of the Safety Specialists and Coordinators: 5%
3. Administration, Education and miscellaneous: 2%

Scope Measures
• Collaborates with sub-group of health care professionals responsible for an aspect of case processing with emphasis on timely Medical Review and appropriate distribution and submission of case of cases to affiliates, partners and Regulatory Authorities
• Responsible for the Causality Assessment for both, developmental and marketed product safety for Individual Case Safety Reports

Knowledge/Skills/Abilities Required
• Health care professional degree required – MD, PharmD or Bachelors Degree in Nursing
• 3+ years previous experience in medical review
• Knowledge of disease pathology and physiology, pharmacology and therapeutics
• Knowledge of International and US Regulatory Requirements
• Ability to work effectively in high paced and team environment
• Strong organizational, written and verbal communication skills
• Previous experience using a Pharmacovigilance Database
• Experience with quality assurance activities; attention to detail

***Note: No remote work. 7.5 work day (+1 h lunch break). Start time is between 7:30 – 8:30 am only.
Source: Job Diva – Job Listing

Associate Director, Marketing (19-00740) – NJ – Woodcliff Lake

Associate Director, AD Global Brand, Dementia Total Inclusive Ecosystem

Job Summary
• Assist in building brands In a new market – where to play, how to win choices to drive launch
• Assist on building the HCP and patient (consumer) strategy
• Coordinate all tactical plans and ensure the tactical plans are on track
• Lead patient/consumer promotion initiatives – execution for digital, social and any other channel identified as a key media for
• Support the development of a competitive readiness plan to defend against new market entrants (and failed therapies)
• Manage tactical execution and work with vendors for the tactics
• Ensure compliance with Client policies and procedures and full integration into Client culture and support resources

Essential Functions
Responsibilities
Percent of Time
– Execute required projects to lead establishing global strategy and launch preparation for branding and marketing imperatives 25%
– Support all market research initiatives for Global AD portfolio such as patient journey, physicians perspective, epidemiological survey for forecasting, testing and interviewing for brand development 25%
– Assist in successful communication with regional stakeholders to support launch preparation with each unique market characteristics and regional specific situation. 25%
– Support congress related commercial activities for Global Core congresses and regional important congresses to have unified corporate and brand messages 20%
– Support DTIE internal communication between Japan and US to establish efficient project and budget management 5%

Scope Measures
This position is not expected to make any independent decisions that would materially impact the company’s financials or external stakeholder opinions, but would participate in the development of materials that lead to recommendations that could have material impact. This position will make independent decisions directly related to analysis of business strategies, project management and internal/external interactions.

Knowledge/Skills/Abilities
Minimum requirement:
1) At least 5-7 years proven experiences in marketing (Global or US/EU)
2) Experience in using market research and other secondary sources of data to support building HCP strategy and branding
3) Familiarity with databases, statistics, product lines, pipelines, LSM and latest medical issues
4) Excellent communication and negotiation skills in diverse
5) Highly motivated strong organizational and time management skills
6) Ability to work with diverse group of people across countries
7) Strong interpersonal skills – need to work within Client and also with Biogen
8) Understands and supports the mission to serve the patient as the key priority

Preferable (but not mandatory) to have experiences:
a) In supporting the launch of a product globally, in country or regionally
b) Graduate or undergraduate degree in sciences
c) Experience in Alzheimer’s Disease/ Neurology
Source: Job Diva – Job Listing

HR Coordinator (19-00739) – MA – Cambridge

Staffing Coordinator

Job Code:
We are looking for an experienced Staffing Coordinator to join our team! As the Staffing Coordinator, you will be responsible for ensuring that our staffing process runs smoothly. In this role you will work with the staffing manager, hiring manager and Human Resources department, to assist in recruiting, interview scheduling, and supporting the immigration department.
Principal Duties and Responsibilities
• Assist in implementing the staffing strategy and process.
• Schedule on-site and telephone interviews between candidate and nterview teams.
• Work with recruiting agencies when needed.
• May assist in candidate screening and interviewing.
• Assist in new employee onboarding, through supporting the immigration process for new hires that require sponsorship.
• Assist in the creation of interview guides, which include standardized interview questions that support the evaluation of key behavioral and leadership competencies.
• Assist in the tracking of staffing and recruiting KPIs.
• Prepare KPI reports.
• Assist in transition to the Workday applicant tracking system.
Qualifications
• Minimum 5 years related experience
• Polished and professional presentation
• Teamwork orientation
• Tremendous attention to detail
• Ability to multi-task
• HR certification, PHR or SPHR a plus
Source: Job Diva – Job Listing

Research Associate I-Mouse ex vivo studies (19-00738) – MA – Cambridge

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.

Reporter assays
Functional assays with primary cell (PBMC or purified cells)
ELISA/AlphaLISA/MSD/Luminex
Flow cytometry
Mouse ex vivo studies
Source: Job Diva – Job Listing

North American Lead Rare Disease: Senior Director, Global Regulatory Affairs (19-00737) – NJ – Bridgewater

The Senior Director of North America Regulatory Strategy (NA GRA) will be primarily responsible for the development of US regulatory strategy to advance ***'s Rare Disease and Rare Blood Disorders portfolios of development pipeline candidates and life cycle management of marketed products. Reporting to the  Associate Vice President of North America Regulatory Affairs, this individual will work within the Global Regulatory Team to provide strategic input and ensure operational execution of US submission activities for the *** Genzyme Rare Disease portfolio. The individual will be responsible to interface directly with the US FDA as the primary contact for the company for assigned programs and lead a small team of North America Regulatory Leads (NARLs)

Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for Rare Disease and Rare Blood Disorders indications which adhere to US regulatory and company guidelines.
Have an understanding of the competitive environment of the various rare disease indications and support NARLs in developing products that are differentiated and provide commercial value as well as value for the patient
Represent the NA GRA perspective as a member of the project-specific cross-functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents.
Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
Accountable to define document content/strategy to align with US regulator expectations.
Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
Represent *** at US FDA for assigned projects.
Work with the NA labelling strategist, Global Regulatory Team Leads, and the Global Regulatory Team to develop the US prescribing information.
Work with and participate on multi-disciplinary matrixed teams to successfully meet project US regulatory deliverables while adhering to regulatory requirements for programs and products.
Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.
Function as a player/coach with an ability and willingness to perform dossier/submission management tasks and develop a high level regulatory strategy for assigned projects.
Supervise, and/or coach mentor, junior staff supporting regulatory team.
Ensure compliance with all regulatory and internal policies

Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
Direct interaction/negotiation with regulatory authorities (e.g. FDA)
Ability to motivate and lead others
Team player, ability to work well within cross-functional teams and in a multicultural/multinational environment
Excellent oral communication and writing skills
Change management/ change enabler: embraces the challenges of a fast-changing environment
Generates innovative solutions in work situations, trying different and Client ways to deal with work problems and opportunities
Excellent operational skills
Unquestionable ethics, professional integrity, and personal values consistent with the *** values
Source: Job Diva – Job Listing

Laboratory Technician I (19-00736) – MA – Framingham

Duties:
•    Setup and support of filtration and chromatography system operations
•    Set-up and maintain general laboratory and  tools/systems
•    Support buffer and potentially cell culture medium  preparations
•    Collaborate with other scientists/engineers across the team,  Development and Manufacturing groups, and conduct necessary experiments to contribute to understanding and interpretation of results; participate in recommending changes or additional experiments
•    Present data and results within department and project teams

Education:
o    Bachelor/Master in chemical engineering/biology/chemistry or related with 0+ year experience

Required Skills:
o    Proficient in Microsoft word, excel, and powerpoint
o    Experience with buffer and/or media preparation
o    Experience with filtration, chromatographyand/or cell culture related operations

 
Source: Job Diva – Job Listing

Clinical Data Manager III (19-00735) – NJ – Parsippany

Duties:
The Clinical Data Manager will lead all the data management tasks to ensure that studies are properly designed and presented to successfully support the product development and the resulting regulatory submissions. Essential Duties & Responsibilities: The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. 1. Represent all aspects of Clinical Data Management (CDM) in a clinical study team environment. Provide advice and solutions to CDM related risks and issues 2. Responsible for the implementation of clinical study database, startup documents, reports, and external data/system planning and incorporation/integration, including but not limited to EDC, IRT, Lab and Central Read data, and integration with CTMS. 3. Manage and ensure CDM quality, timeline and deliverables. Responsible for CDM training, study data collection, data review, query management, medical coding, change management, external data handling, CDM documentation and SAE reconciliation. 4. Responsible for database lock and archival of CDM deliverables and documents. 5. Communicate with other team members, report issues, and coordinate data management related team meetings. Track study data management performance and provide project tracking on an ongoing basis. 6. Perform other data management functions as necessary. Support departmental initiatives.
 
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Skills:
Demonstrated strong knowledge in medical terminology, clinical study protocol, clinical trial process and therapeutic areas. • Demonstrated working knowledge of EDC Clinical databases, Interactive Response Technology, Clinical Laboratory Data, CDISC understanding, SAS dataset structure, MedDRA and WHO-Drug coding dictionaries • Excellent written and verbal English communication skills. • Proven strong attention to detail • Demonstrated organizational and time management skills, ability to meet deadlines.
Excellent MS Office skills including Excel, Word and Power Point

Education:
Bachelor's degree in Science or Medical/Clinical discipline from accredited college or university.
 

Source: Job Diva – Job Listing

Clinical Finance Analyst (19-00734) – WA – Bothell

The Clinical Finance Analyst is responsible for Clinical financial and accounting processes, such as processing invoices and payments to investigators and vendors; reconciling payments with sites, vendors and corporate Finance; creating reports for corporate Finance and Development departments; and ensuring current insurance information and documentation is conveyed appropriately to the insurance broker.
Source: Job Diva – Job Listing