Senior Manager, Biologics Drug Product Development

🕒 il y a 18 jours

🇺🇸 États-Unis – Télétravail

💵 $150 034 - $224 250 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 0%

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Otsuka Pharmaceutical Companies (U.S.)

Site WebLinkedInTous les Emplois

1001 - 5000 employés

💊 Pharmaceutique

🏥 Santé

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.

Description

• Provide technical leadership for Drug Product development activities across multiple biologics programs • Lead technical due diligence for Drug Product functions supporting in/out licensing opportunities • Lead formulation design and characterization for parenteral biologics • Design and optimize phase-appropriate formulations using QbD principles and DoE • Develop high-concentration and liquid-stable protein formulations • Conduct stability and stress studies and establish degradation pathways • Develop and execute shipping studies to establish and validate commercial shipping lanes • Perform or direct analytical and biophysical characterization studies 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 • Assess container closure systems and partner 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 support regulatory responses • Ensure compliance with cGMP and global health authority expectations • Lead or participate in FMEA risk assessments, deviation/CAPA resolution, and change control • Collaborate with Analytical Development, MSAT, Manufacturing, QA, Supply Chain, and Regulatory • Mentor junior scientists and contribute to portfolio planning and timelines

🎯 Exigences

• Degree in chemistry, biochemistry, chemical engineering, or biology and relevant practical experience in a cGMP-regulated environment • Bachelor’s degree with 10+ years of work experience, or Master’s degree with 7+ years of work experience, or PhD degree with 5+ years of work experience • Expertise in formulation development for protein therapeutics, including excipient screening, stability/stress studies, and biophysical characterization • Hands-on experience 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 • Experience with high-concentration proteins, viscosity management, syringeability/injectability, and device compatibility • Experience with visual inspection, container closure integrity, and leachables/extractables • Familiarity with sterile filtration and fluid path design • Practical knowledge of cGMP, Annex 1, ICH Q8/Q9/Q10, ALCOA+, and 21 CFR Part 11 • Strong technical writing skills and experience with tech transfer to GMP or CDMO sites • Willingness to travel up to 25% of the time • Proficiency in statistical analysis, DoE tools, JMP/Minitab, and QbD control strategy development

🏖️ Avantages

• 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 • Other company-provided benefits