With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
We are seeking a highly skilled and detail-oriented Contractor to support our ANS team with documentation and data review activities related to routine QC tasks, including but not limited to Tech transfer, GMP release and stability testing. The ideal candidate will possess strong knowledge of compliance, technical expertise in separation-based analytical techniques (e.g., HPLC, GC, CE-SDS) including compendial testing and have a solid understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Responsibilities
- Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data
- Works collaboratively with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals
- Support Product Release activities ensuring timelines are met
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
- Identify and resolve issues with assistance from Data Review team
- Review of LIRs
- Support all data integrity initiatives and strive for right first time
- Make sound daily decisions about the quality of data based on biochemical knowledge and compliance background
- Revise, create SOPS and/or test forms as required
- Assists with metrics for trending and reporting as required, stability and QC analytical data
- Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
- Exceptional communication and interpersonal skills
- Strong knowledge of QC analytical equipment and software required
- Strong communications skills – written and verbal
- Able to prioritize workload to meet stringent timelines
- Provide timely status updates to Management upon request
- Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
- Performs other duties as assigned
Qualifications
- B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
- 5+ years in a cGMP analytical laboratory environment
- 3+ years in Quality data analysis/review experience
- Working knowledge of HPLC, UPLC, LC-MS
- EMPOWER
- cGMP experience
- Experience with stability testing and strong familiarity with ICH guidelines, including but not limited to: ICH Q1A–Q1E (Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products)
- Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
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