Senior Manager, Biologics Drug Product Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide technical leadership for Drug Product development initiatives across various biologics programs.

• Oversee technical due diligence for Drug Product functions that support in/out licensing opportunities.

• Direct formulation design and characterization for parenteral biologics.

• Create and optimize phase-appropriate formulations utilizing QbD principles and DoE.

• Develop high-concentration and liquid-stable protein formulations.

• Conduct stability and stress studies while establishing degradation pathways.

• Plan and execute shipping studies to establish and validate commercial shipping lanes.

• Perform or supervise analytical and biophysical characterization studies in collaboration with Analytical Development.

• Develop and scale automated aseptic filling processes from small/pilot scale through clinical and commercial production.

• Define and implement control strategies, validation protocols, and process characterization studies.

• Optimize and validate filling accuracy and precision; establish in-process controls and line setup procedures.

• Implement single-use fluid paths, component preparation, and sterile filtration strategies.

• Evaluate container closure systems and collaborate on vendor and component qualification.

• Author and review process descriptions, batch records, and tech transfer packages.

• Execute transfers to internal GMP or CDMO sites and provide on-floor support during engineering runs, PPQ, and campaigns.

• Author protocols and reports, contribute to CMC Module 3 sections, and assist with regulatory responses.

• Ensure compliance with cGMP and expectations set by global health authorities.

• Lead or engage in FMEA risk assessments, deviation/CAPA resolution, and change control processes.

• Collaborate with Analytical Development, MSAT, Manufacturing, QA, Supply Chain, and Regulatory departments.

• Mentor junior scientists and assist in portfolio planning and timeline management.

⛳️ Requirements

• A degree in chemistry, biochemistry, chemical engineering, or biology with relevant practical experience in a cGMP-regulated environment.

• Bachelor’s degree with 10+ years of experience, a Master’s degree with 7+ years of experience, or a PhD with 5+ years of experience.

• Proficiency in formulation development for protein therapeutics, including excipient screening, stability/stress studies, and biophysical characterization.

• Hands-on experience in developing automated aseptic filling processes for vials and/or PFS/cartridges in isolator/RABS setups.

• Experience with filling system setup and optimization using peristaltic, piston, or time-pressure systems.

• Familiarity with high-concentration proteins, viscosity management, syringeability/injectability, and device compatibility.

• Experience with visual inspection, container closure integrity, and leachables/extractables.

• Knowledge of sterile filtration and fluid path design.

• Practical understanding of cGMP, Annex 1, ICH Q8/Q9/Q10, ALCOA+, and 21 CFR Part 11.

• Strong technical writing abilities and experience with tech transfers to GMP or CDMO sites.

• Willingness to travel up to 25% of the time.

• Proficient in statistical analysis, DoE tools, JMP/Minitab, and QbD control strategy development.

🏝️ Benefits

• Incentive opportunity.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-provided basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) match.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.