Clinical Pharmacology Scientist III (20-00767) – MA – Cambridge

Summary:
Leads the PK Sciences strategy and influences project strategy during discovery and/or clinical program. Collaborates within the cross-functional team to identify and mitigate key project issues related to the PK Sciences discipline (PK, PK/PD, IG, metabolism and clinical pharmacology).

Major Accountabilities:
1. Independently represents PK Sciences a core member of discovery, translational medicine and global project teams.
2. Participates or leads PKS sub-team to define PKS strategy for compound progression and development.
3. Manages study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools.
4. Responsible for the timely and effective communication of data, strategy, results, impact to the project teams.
5. Aligns plans and strategies with sub-teams, project teams, manager and leadership team.
6. Analyze and interpret PK/TK/PD/IG data generated during discovery, early and full development; present results to the program.
7. Proactively identifies potential project hurdles, provides solutions and contributes to contingency plans.
8. Independently authors and prepares key pre-clinical and clinical, and regulatory documents including, but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
9. Actively participates in cross-departmental teams, department-wide initiatives and work streams.
10. Provide PK Sciences expertise on due diligence and prepare appropriate documentation.
11. Publishes internally or externally as main contributor to enhance Company and PK Sciences visibility.
12. May mentor and train other PK Science Associates.
13. Completes all required organizational trainings and requirements according to corporate timelines
14. Adhere in strict accord to the appropriate SOP and GxP guidelines.

Skills:
Extensive understanding of drug metabolism and pharmacokinetic principles.
Good understanding of clinical pharmacology strategy in drug development and registration.
Experience in drug discovery characterization.
Proficiency with key software for PK analysis and PK modeling (e.g. Phoenix).
PK/TK study design expertise.
Clinical study design for clinical pharmacology studies.
Regulatory knowledge of area of CP & Biopharmaceuticals.

Education:
PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic background.
Source: Job Diva – Job Listing

Research Associate II/III (20-00763) – WA – Bothell

Summary:
We are seeking a highly capable and motivated laboratory-based Research Associate with a technical background in cell line generation and assay development.
This RA will be a part of the team that generates therapeutic antibodies for our preclinical programs in oncology.
The primary responsibilities will include engineering cell lines and validating their use in flow cytometry and functional assays for use in hybridoma screening.
The candidate should work well within a highly collaborative team environment, while being able to work independently to design, execute, troubleshoot, optimize, and interpret experiments.
Specific position level will be commensurate with applicant’s experience.

Responsibilities:
• Design, execute, troubleshoot, optimize, and interpret experiments
• Utilize transfection, CRISPR/Cas9 tools, and lentiviral transduction for the generation of stable cell lines
• Design constructs for use in cell line generation, both for overexpression and knockout
• Evaluate target expression and validate antibody reagents by flow cytometry
• Design and optimize cell-based assays for lead antibody characterization, which may include ligand blocking assays or cytotoxicity assays
• Coordinate workflows with cross-functional teams, project leads and CROs
• Keep detailed and accurate laboratory records, communicate results in written and oral format, and present results at group meetings and cross-departmental meetings
• Maintain laboratory spaces, equipment, and supplies

Qualifications:
• 3+ years of experience in an academic, biotech, or pharmaceutical research setting
• Requires 1+ years of experience in cell line generation, and must include transfection, CRISPR/Cas9 tools, and lentiviral transduction
• Requires hands-on experience staining cells for flow cytometry and running the instrument independently
• Familiarity with antibody discovery or antibody characterization is highly desired, but not necessary
• Demonstrated ability to work both independently and as part of a team in a fast-paced dynamic environment
• Demonstrated ability to successfully handle multiple projects simultaneously, while tracking goals and performance on team deliverables
• The ability to be flexible and shift individual and team priorities based on leadership and/or company changes
• Ability to generate high quality documentation and communicate effectively to a variety of audiences through oral and written formats
• Team player and solution-oriented, with strong analytical, interpersonal, organizational and time-management skills
Source: Job Diva – Job Listing

Scientist (20-00762) – AZ – Tucson

POSITION SUMMARY: Responsible for initiating, directing and executing scientific research, development and manufacturing process strategies to support new and existing products. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the art principles and theories. Makes contributions to scientific literature and conferences. Serves as an in-house and outside consultant. May act as a spokesperson for corporate scientific affairs and advise top management. Participates in development of patent applications. Promotes and participates in the professional development of scientists and laboratory facilities. Uses professional concepts to contribute to the development of product or process principles and to achieve objectives in creative and effective ways. ESSENTIAL FUNCTIONS: – Conducts research and development activities for products, methods and/or processes. – Projects are assigned with defined scope and goals. – Direction is provided by more senior scientists, management or project leader. – Participates in efforts to define new components, products or processes and identify technical challenges. – Makes suggestions to improve work processes. – Creates potentially patentable components for systems, reagents or processes. – Plans and executes assigned projects; utilizes thorough technical and theoretical understanding of numerous techniques. – Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements. – Applies advanced scientific knowledge to projects. – Executes experiments; participates in experimental design. – Utilizes DOE where appropriate. – Participates in cross functional technical team activities. – Shares knowledge and expertise with others. – Participates in project planning, process updates and contributes to experimental design. – Prepares and delivers presentations of project results to own or other groups. – Monitors work to ensure quality, and continuously promote Quality First Time.

Knowledge, Skills, and Abilities: – Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought. – Strong understanding of scientific principles and concepts. – Applies advanced technical writing skills to produce reports and documents.
Source: Job Diva – Job Listing

USA-Biostatistician with SAS Programming III (Clinical) (20-00760) – NJ – Bridgewater

Perform tasks under the guidance of project lead or CMS departmental principals on analytic design and statistical analytic planning, coordinate real world database management, and data warehouse construction or maintenance. Develop documentations of analytic plans, prepare for statistical concept communications and be able to advise on analytic strategies and recommend methodological solutions on complex analytic topics. Lead and perform statistical analyses, modeling, reporting, analytic interpretations, and slide development. Develop SAS macro libraries to standardize disease identification, cohort constructions, mapping of healthcare resource utilization and expenditures to standard metrics for product value propositions. Construct drug coding systems to support database activities for key therapeutic R&D and brand LCM activities, and establish and maintain a repository of the coding systems for therapeutic medications, diagnostic or surgical procedures and drug delivery systems. Establish and main variety of disease identification and composite comorbidity assessment tools and algorithms. Conduct analytic quality assurance procedures. Provide timely analytic support for abstract and manuscript development and submissions to medical/scientific congresses or publications. Provide analytic support for internal and external communications and statistical interpretations of data under the guidance of departmental methodological principles. Develop statistical analytic plans, statistical expertise and data management techniques and skills. Manage real world database operations, analytic programming and statistical modeling activities. Assist project lead or departmental principals in study design, power calculation, CRF construction, analytic operations and reporting for retrospective and prospective studies. Assist project lead or departmental principals in analytic/computing resource planning, work flow management and prioritization, and related logistic coordination. Prepare communication materials on analytic projects including processes, data, analytic findings for internal and external functional groups within or outside of CMS. Prepare slide decks for congress or manuscript submissions or internal or external communications. Plan and initiate analytic projects using the real world databases or clinical trial data warehouse in support of the CMS initiatives. Provide consultation for all CMS groups on research methodology and statistical or analytic issues. Vendor Management. Database licensing and maintenance. Analytic process formulation and standardization. Potentially supervising team of analytic and programming support. Years of Experience: 6 – 9 Years
Source: Job Diva – Job Listing

Data Engineer (20-00758) –

Data engineer/analyst: will help with cleaning and pre-processing data sets, merging data, and running analyses. This position will be part-time, with potential for full-time, depending on skill set.

1)Data Engineer

Required

  • Experience on data processing with batch flat files
    • Data cleaning, merging data sets, time synchronizing, handling missing data points
  • In-depth knowledge of databases and graph database
  • Python programming experience: general scripting data cleaning, data modeling, API with various database
  • Data pipelining and ETL (data acquisition, cleaning, transformation)
  • Data visualization

Desirable

  • Knowledge of graph model
  • Experience writing SQL queries or Cypher
  • Statistical analysis experience (research or professional)
  • Machine learning experience (research or professional, regression methods meet this requirement)

Likely academic background

  • Experience is more important than academic background
  • Somebody with a computer science degree is likely to have the likely skills, but someone with almost any degree could have developed the skills in school or at work.

Source: Job Diva – Job Listing

Power Engineer (20-00757) –

Required

  • Electrical Engineer on power system master’s degree or higher (strong experience could substitute)
  • Knowledge of basic power system analysis: topology processing, contingency analysis and power flow
  • Experience on event analysis and optimal power flow
  • Programming experience: python

Desirable

  • Theoretical background in power system operation and stability
  • Knowledge of real-time applications and measurements (SCADA system)
  • Experience with machine learning

Source: Job Diva – Job Listing

Process Technician (20-00755) – PA – Exton

Summary:
Under supervision and guidance, the Process Technician will be responsible for hand-on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant. In addition, the individual will execute and participate in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances, including operation of cell culture bioreactors and harvest equipment, GMP documentation, and ensuring compliance to relevant regulations.
 
Work in a hands-on capacity in the operation of upstream equipment for the manufacture of preclinical, clinical, and commercial biologics drug substances.
Ability to follow oral and written instructions, maintain neat, accurate, and current training and cGMP records.
Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.
Perform process performance sampling/ in process testing supporting the manufacturing.
Maintains, inventories, and transports all required equipment, materials, supplies and products. Some heavy lifting is expected.
Participate and contribute in the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment. Assist and contribute in the commissioning of new equipment for upstream manufacturing. Participation in other areas within the facility may be added at the company’s discretion.
Assist in equipment maintenance and calibration with appropriate internal departments. Provide cross-functional support for other departments within the pilot plant at the discretion of management.
 
The individual will play a hand-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical, clinical, and commercial biologics drug substance to support Client’s pipelines. Execution of manufacturing in the GMP production suites including documenting data compliantly.
 
Specifically, this person will participate and contribute to the success of the cell culture and harvest equipment operation and processes for the manufacture of materials for global clinical supplies. The individual will also participate in monitoring and maintaining the production area processes to remain compliant to regulations. The individual may also supporting a campaign and may provide cross-functional support for other departments within the pilot plant at the discretion of management.
 
Required:
Two-year Associate degree or Four-year BS in Biotechnology or (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree is strongly preferred.
Experience:
Minimum of 2-4 year (Associate degree) or 0-2 year (BS) practical scientific experience.
Ability to follow direction, work under supervision, and demonstrate capability in organizing complex activities in a cGMP production process.
Basic skills in executing routine production, maintenance, and operation of upstream cell culture and harvest equipment. Must have a Mechanical aptitude.
Good aseptic technique in maintaining process sterility.
Good written, communication, and interpersonal skills with the ability to work in a team environment required.
Capabilities in the operation of all area-specific production equipment such as large scale stir tank and/or single-use disposable bioreactors, centrifuge, micro-filtration, and CIP/SIP operations is a plus.
Previous exposures to cGMP, EMEA, and JP regulations as a plus.
Source: Job Diva – Job Listing

USA-Manufacturing Technician I (Manufacturing/Quality) (20-00752) – MA – Framingham

Position Summary
Work with a team of 10-12 manufacturing operators to complete daily production schedule and manufacturing responsibilities.
Core Responsibilities
Performs Seprafilm inspection and operators manufacturing processing equipment inside and environmentally controlled area in accordance to establish SOPs and safety regulations.
Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs.
Perform routine cleaning procedures for the manufacturing controlled area.
Perform all aspects of a computer based inventory/production control system and maintain production data base.
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make  a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Basic Qualifications:
High School Diploma and 3+ year experience in cGMP manufacturing environment.
Basic computer skills, basic math and problem-solving skills.
Ability to multi-task.
Ability to read and comprehend instructions, short correspondence, and memos.
Preferred Qualifications:
Good documentation skills.
Special Work Conditions:
Required to work with hazardous materials.
Requires physical demands of lifting up to 30 pounds.
Must be willing to work weekends or required to work overtime to meet production demands.
Source: Job Diva – Job Listing

USA-Quality Control Analyst I (Manufacturing/Quality) (20-00751) – MA – Framingham

Perform operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provide an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Complete routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aid in the development of test methods. Conduct data review and preliminary evaluation of results. Solve problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provide input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contribute to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.. Years of Experience: 0 – 3 Years, Shift is Wednesday – Saturday.
Source: Job Diva – Job Listing

USA-Regulatory Affairs Specialist III (Clinical) (20-00749) – NJ – Bridgewater

Manage Vault Registration Tracking for regulatory CMC submission for investigational new drug application (IMPD/IND) and marketing authorization application (NDA/MAA).
Represent RA CMC managers to ensure the proper entry of CMC registration information in alignment with process.
Plan, manage and track status of regulatory CMC submissions and related administrative activities, including information and data entry and uploading submission documentation.
Maintain up-to-date CMC registration tracking including updates to registered information and report on approval status and Health Authority correspondences.
Manage CMC registration tracking activities including creation, initiation of workflow, closing and archiving in Vault.
Communicate effectively with RA CMC managers.
​Years of Experience: 3 – 6 Years.
Source: Job Diva – Job Listing

USA-Production Planner II (Professional) (20-00748) – TN – Chattanooga

Responsible for the planning and scheduling of Chattem in-house and third party manufacturer (TPM) production to support corporate service level and inventory objectives.

Job Responsibilities
Develop 12-month rolling Master Production Schedule (MPS) and Capacity Plan based upon Operations Sales Forecast.
Convert MPS into detailed production line schedule for short range (2-3 month) horizon balancing inventory needs, capacity utilization and changeover impact.
Coordinate with Plant Operations, Procurement, Quality Assurance, Customer Service and Distribution to ensure timely execution of production schedule and fulfillment of customer sales orders.
Provide component/ingredients needs to Materials Planning or Procurement from Materials Requirement Plan (MRP).
Participate in monthly Operations Sales Forecast consensus meetings with Demand Planning, Marketing, Sales and Finance making recommendations based upon observed sales trends to help forecast accuracy.
Establish and maintain Item Master, Bills of Materials and Routings within JD Edwards (JDE) system.
Develop and maintain Standard Packaing Instructions (SPIs) for use on Chattem packaging lines.
Prepare inventory obsolescence reports as required for review with Supply Chain, Marketing and Finance.
Plan and implement packaging and/or product changes consistent with Marketing objectives, while minimizing inventory obsolescence.
Plan new product or line extension launches consistent with Marketing & Sales timelines.
Source: Job Diva – Job Listing

USA-Cost Manager/Cost Engineer/Planning Manager/Schedule Engineer I (Engineering) (20-00747) – TN – Chattanooga

BASIC FUNCTION:
This position will be responsible for leading commercial product support, scale-up/validation activities, and providing plant technical support. Duration is November 20 through April 21.

SCOPE OF RESPONSIBILITIES:
1. Lead Quality by Design, Scale-up, and Validation projects for over-the-counter product launches and process optimizations
2. Manufacture pilot feasibility and stability batches to support scale-up for new product launches
3. Perform bench scale work to understand and determine critical processing parameters
4. Execute process improvement initiatives to improve compliance and efficiency
5. Develop strategies for execution of process, packaging, equipment, and cleaning validations
6. Create and execute Validation Protocols and issue reports to qualify new processes or process optimizations
7. Generate and analyze statistical data to support validation protocols, investigations, and annual validation reviews
8. Design and execute batch record creation and modifications
9. Support deviations and incident investigations related to pilot, validation, and plant activities
10. Lead equipment and cleaning requalification reviews to ensure equipment and processes remain in a validated state.
11. Provide technical support for Plant Operations

EDUCATION, EXPERIENCE, SKILLS:
1. 4-Year science or engineering degree minimum
2. Experience in a drug/OTC GMP Manufacturing environment
3. Product formulation and processing experience.
4. Collaborative-minded with excellent planning and organization skills
5. Independently action-oriented
6. Strong written and verbal communication skills
7. Strong analytical skills with ability to analyze problems, identify key issues, and develop strategic and tactical solutions
Source: Job Diva – Job Listing

Site Reliability Engineer (20-00746) –

We're looking for a talented SRE to join the IT Infrastructure team. You'll help us build nimble, secure, and scalable systems that are pivotal to our growing company. Instead of settling for easy solutions, you challenge yourself and your team to dream up and build even better ones. You should have strong systems skills and deep knowledge of IT best practices and technology.  AWS experience is a must.

What you'll do:

  • Architect and build our core internal services to scale globally and endure security threats

  • Work cross-functionally with stakeholders to understand requirements and build solutions accordingly

  • In particular, advance our security posture by interfacing with our Security team and executing on a roadmap

  • Demonstrate ownership over services and solutions delivered by the team

  • Build our cloud-based and physical systems platforms

  • Assess our current infrastructure and evolve it to become cohesive and scalable

  • Script and automate your way out of problems

  • Spend your time building services, not running servers

  • Mentor more junior members of the team

Skills:
  • Minimum six years experience as a systems engineer; at least two years of in-depth experience with AWS

  • Experienced with modern cloud infra tools including but not limited to Docker, Terraform, Ansible, and K8s

  • Experience working within regulatory frameworks such as SOX

  • Experience building and managing authentication systems such as OpenLDAP, FreeIPA, SAML, or oAuth

  • Strong *NIX and TCP/IP fundamentals, particularly in public cloud environments

  • Fluent in at least one software development/scripting language, ideally Python

  • Background in certificate authority management is a plus

This role will be 100% remote. Worker must be in the US, but timezone doesn't matter.
Source: Job Diva – Job Listing

SEcurity Engineer (20-00744) –

**REMOTE POSITION – OPEN TO CANDIDATES FROM ANYWHERE IN US**

Perform third-party vendor due diligence as part of Client's process for using new and existing vendors to perform services or where client shares data with a vendor. This role will also entail responding to inbound due diligence requests from third parties who work with our Ads & Marketing teams. 

Consult with internal Security team and stakeholders to understand risks of vendors and the impact they may have on client.

Review vendor submitted security questionnaires and assess compliance against  client requirements

Analyse vendor submitted evidence to corroborate security questionnaire

Conduct security review calls with vendor stakeholders

Work with internal teams to specify proper integration mechanisms where appropriate.

Respond to inbound due diligence requests to represent client's security standards to third parties.

 

Skills:
    • Understanding of security policies and practices especially in the areas of basics of compliance, IT general controls, etc

    • Ability to work autonomously

    • Good judgement and confidence to take a risk based approach to analyse situations

    • Great communication skills (written, aural and oral) and strong customer service attitude

    • Service delivery skills and takes pride in representing the team in all scenarios

Education:

None required, though bachelors likely for appropriate candidates. CISSP, and CISA along with other recognised industry qualifications not explicitly required but will be taken into consideration.

 

Source: Job Diva – Job Listing

Compound Hub Operator (20-00741) – MA – Cambridge

The Sample Management group is looking for a highly motivated individual to be a key contributor within our team. As a member of the Sample Management group, the successful candidate will be primarily working within the Compound Hub, processing new compounds and inventory requests through the Compound Hub Process
Key Functions:
Primary responsibility will be handling of all new compound orders, weighing solid samples within a weigh hood using an analytical balance in order to create solutions, which then move onto the v Tecan Liquid Handler.
Sample logistics including packaging and unpackaging samples from both internal and external locations.
Responsible to ensure all service level agreements are achieved on a daily basis and to work with scientific staff directly to complete orders.

Job Requirements:
A Bachelors degree with experience working in a scientific lab, having an emphasis on compound inventory management and distribution utilizing automated systems
Should have a thorough knowledge of activities related to compound management, including inventory management, solution production, quality control and logistics management
Experience working with laboratory robotics
Ability to diagnose and triage hardware and software issues quickly
Good personal and communication skills.
Ability to work well within a team
Ability to multitask in a fast paced environment
Must understand customer focus, and be professional in the work place
Must be self-motivated, well organized, reliable and able to prioritize workload
Working knowledge of MS Office products
Desired Traits & Experience:
This is a service orientated position requiring attention to detail, ability to work as part of a team and interact routinely with the scientific staff.
Knowledge of some or all of the following instruments/systems are required: Tecan evo, Biomicrolab Volume Checker, Biomicrolab Tube Sorter
Source: Job Diva – Job Listing