Job DescriptionAbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVie's pipeline of innovative therapeutic biologic products. We are a world-class team of scientists and leaders united by a shared mission to advance industry-leading analytical capabilities and meaningfully contribute to the advancement of AbbVie's pipeline of innovative medicines.
The Biologics ARD team at the AbbVie Bay Area site in South San Francisco has a long and rich history of biologics development. Located in a state-of-the-art facility housing end-to-end CMC development capabilities, the team works collaboratively to advance novel biologic therapeutics - including multi-specifics, ADCs, antibodies, and novel modalities - into first-in-human clinical development and through to clinical proof of concept. Careers in AbbVie Biologics ARD provide unique opportunities to work with cross-functional and global teams to drive exceptional science and innovative product development strategies.
Role SummaryWe are seeking an experienced and highly motivated Scientist II to join our Quality Control team focused on early stage (first in human through Ph 2 clinical) development. The Quality Control team is responsible for a wide range of Quality Control GxP activities, including change management, document management, coordination of outsourced release and stability testing, shelf-life evaluation, preparation of Certificates of Analysis and coordination of the exception/quality event process. In this role, you will represent the QC function on one or more program teams, with responsibility for authoring quality documents and regulatory submission sections. You will collaborate with Technical and Quality SMEs to achieve QC deliverables for release of GMP drug substance and drug product batches to enable clinical supply, as well as manage shelf-life assignment for clinical batches.
Responsibilities:- Represent the QC function on cross functional program teams.
- Collaborate with analytical leads to achieve release and stability program deliverables.
- Author quality documents and IND/IMPD sections to enable regulatory submissions and clinical supply.
- Evaluate and trend stability data using JMP or other statistical software to support retest dating and shelf life assignments.
- Prepare and review/verify quality control documents, including certificates of analysis, reference standard qualification reports, release & stability protocols, data packages and stability reports.
- Initiate and review change records in collaboration with Technical and Quality SMEs and stakeholders.
- Provide support during internal and external audits and inspections.
- Serve as a subject matter expert for GxP quality system document management activities and coordinate closely with document authors, owners, stakeholders and approvers to initiate and complete document workflows within target timelines.
- Ensure compliance with SOPs, standards, and requirements.
Qualifications- BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
- Must have a minimum of two years hands-on experience:
- Lab experience with methods commonly employed for release and stability testing of antibody therapeutics.
- Evaluating and trending of GMP stability data for drug substance and drug product shelf-life assignment.
- Use of data analysis tools (e.g. JMP) and LIMS systems.
- Document management in the biopharmaceutical industry, including GxP electronic document management systems.
- Working in a GxP regulated environment.
- Effective interpersonal, collaboration and communication skills.
- Must have a proactive approach and independently follow through with responsibilities.
- Must be adaptable and flexible in the face of evolving priorities and timelines.
- Well-developed data and time organization/management skills with a high attention to detail.
Work Environment - This position is an on-site role. To be successful, candidates must enjoy and thrive in an on-site, highly collaborative environment with daily face-to-face cross-functional interactions between scientists and colleagues.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
