Analytical Development Scientific Integrator, Biotherapeutics
About The Position
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Therapeutics Development, and Supply (TDS), Analytical Development (AD) group is seeking a Principal Scientist for an Early Development Analytical Scientific Integrator role. The candidate will lead cross-functional analytical teams for biopharmaceutical programs in early stage clinical development for monoclonal antibodies, multispecifics, fusion proteins, and protein conjugates. This individual will provide technical and strategic leadership to analytical teams and represent Proteins Development AD on the Chemistry, Manufacturing, and Controls (CMC) team(s).
Requirements
- A minimum of a Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 8 years of experience in biopharmaceutical development is required.
- A minimum of 2 years of experience on cross-functional CMC teams or analytical sub-teams with the ability to lead and execute complex plans/deliverables in a matrix environment is required.
- Knowledge of biotherapeutic development and analytical strategy including analytical protein characterization, separation techniques, and biological potency assays is required.
- Experience authoring and reviewing CMC sections of clinical trial applications (INDs/IMPDs) and addressing health authority questions is required.
- Must have strong leadership, communication, interpersonal, and negotiation skills and be able to collaborate across teams in a matrix environment
Nice To Haves
- A Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline with at least 3 years of experience in biopharmaceutical development is preferred.
- Experience with the development and registration of protein conjugates is a plus
Responsibilities
- Provide strategic and technical leadership in analytical development and lead a cross-functional scientific team consisting of members from each of the AD sub-functions.
- Represent AD on the CMC team and accountable for all AD project deliverables.
- Lead the execution of critical quality attribute (CQA) assessment, analytical control strategy, and product specifications for programs.
- Lead the analytical review of programs at governance meetings with support from subject matter experts.
- Accountable for submission of complete, consistent, and high-quality regulatory documents to health authorities.
- Effectively communicate project status/overview, resources, budget, and issues to senior management.
- Accountable for project risk management including development of appropriate mitigation strategies and escalation to senior management.
- Interact with and influence various stakeholders outside of DPDS including Manufacturing, Regulatory, Quality, Discovery, and external partners.
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Principal
