Senior Scientist, Process Analytics
Bristol Myers Squibb
2 hours ago
On-site
Devens, MA
Operations
Responsibilities
- Independently design, execute, interpret, and report complex analytical studies supporting process characterization and investigations.
- Serve as SME for CE-SDS, SEC, RP-HPLC/peptide mapping, iCIEF, glycan analysis, and titer methods; lead readiness/qualification for assays entering major campaigns.
- Troubleshoot and improve method performance (robustness, variability, system suitability) to enhance data quality, efficiency, and reliability.
- Own weekly task assignment and coverage for the PA lab; review studies, volumes, timelines, capacity, and sampling plans; coordinate priorities/special testing/sample drop-offs; escalate bottlenecks and rebalance work.
- Partner cross-functionally (Process Development/Engineering, Manufacturing, Quality, MS&T) to ensure analytical readiness for tech transfer/scale-up; represent PA on project teams.
- Author technical memos, qualification packages, and study reports; ensure data capture/review/verification align with PA practices, ELN/DevLIMS, and data-integrity expectations.
Qualifications / Required / Preferred Skills
- BS with 7–9 years, MS with 4–6 years, or PhD with 2–4 years experience.
- Knowledge in bioprocess engineering/analytical or manufacturing sciences (biochemistry, chemical engineering, biotechnology, or related) or equivalent experience.
- Mastery of SOPs, cGMPs, ALCOA+ data integrity in regulated biopharmaceutical environments.
- Experience supporting biologics manufacturing data (upstream/downstream).
- Process technical transfer experience (analytical readiness for engineering runs, PPQ, commercial); ability to assess risk and define mitigations.
- Expertise with SEC-UPLC, CE-SDS, RP-HPLC/peptide mapping, iCIEF, HILIC glycan analysis; ELISA assays (HCP, rProtein A); titer methods; Waters UPLC (ACQUITY Classic/H-Class/Premier); Empower/ELN (e.g., Symyx), LIMS/DevLIMS, Spotfire; project/operational management; strong written/verbal communication.
Benefits (explicit)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k), disability, life/accident insurance, and other listed financial protections.
- Paid time off and flexible time off/paid holidays (varies by location/role type).
Application instructions
- Apply even if your resume doesn’t perfectly match.
- Independently design, execute, interpret, and report complex analytical studies supporting process characterization and investigations.
- Serve as SME for CE-SDS, SEC, RP-HPLC/peptide mapping, iCIEF, glycan analysis, and titer methods; lead readiness/qualification for assays entering major campaigns.
- Troubleshoot and improve method performance (robustness, variability, system suitability) to enhance data quality, efficiency, and reliability.
- Own weekly task assignment and coverage for the PA lab; review studies, volumes, timelines, capacity, and sampling plans; coordinate priorities/special testing/sample drop-offs; escalate bottlenecks and rebalance work.
- Partner cross-functionally (Process Development/Engineering, Manufacturing, Quality, MS&T) to ensure analytical readiness for tech transfer/scale-up; represent PA on project teams.
- Author technical memos, qualification packages, and study reports; ensure data capture/review/verification align with PA practices, ELN/DevLIMS, and data-integrity expectations.
Qualifications / Required / Preferred Skills
- BS with 7–9 years, MS with 4–6 years, or PhD with 2–4 years experience.
- Knowledge in bioprocess engineering/analytical or manufacturing sciences (biochemistry, chemical engineering, biotechnology, or related) or equivalent experience.
- Mastery of SOPs, cGMPs, ALCOA+ data integrity in regulated biopharmaceutical environments.
- Experience supporting biologics manufacturing data (upstream/downstream).
- Process technical transfer experience (analytical readiness for engineering runs, PPQ, commercial); ability to assess risk and define mitigations.
- Expertise with SEC-UPLC, CE-SDS, RP-HPLC/peptide mapping, iCIEF, HILIC glycan analysis; ELISA assays (HCP, rProtein A); titer methods; Waters UPLC (ACQUITY Classic/H-Class/Premier); Empower/ELN (e.g., Symyx), LIMS/DevLIMS, Spotfire; project/operational management; strong written/verbal communication.
Benefits (explicit)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k), disability, life/accident insurance, and other listed financial protections.
- Paid time off and flexible time off/paid holidays (varies by location/role type).
Application instructions
- Apply even if your resume doesn’t perfectly match.