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Company

Apogee Therapeutics · 3 days ago

Director, Drug Product Development

United States

Full-time

Remote

Director/Executive

$200K/yr - $225K/yr

12+ years exp

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BiotechnologyLife Science

No H1B

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Responsibilities

Define and develop robust biologics drug product processes across the portfolio

Oversee drug product manufacturing including tech transfer, process development, and GMP manufacturing operations including person in plant support

Manage drug product CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members

Support phase-appropriate strategies for drug product development, process transfer and scale-up as required, and late-phase commercial readiness

Collaborate with drug product development and device teams to develop drug product presentations in vial, pre-filled syringe, and/or autoinjector

Perform risk assessments using a QbD approach to define drug product process development and manufacturing strategies

Trend manufacturing data and identify opportunities for process improvement and optimization

Support formulation development and optimization for high concentration, injectability, compatibility, and shelf-life throughout product development lifecycle

Collaborate to develop and optimize biologics co-formulations and drug product presentations

Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations

Communicate findings and progress through presentations and reports

Support authoring of regulatory submissions (IND, IMPD, BLA, briefing books, etc.)

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Drug product developmentAseptic manufacturingFormulation developmentCGMP complianceRegulatory submissionsTech transfer managementRisk assessment (QbD)Biologics commercializationCollaboration skills

Required

Minimum of 12 years industry experience in drug product development and manufacturing

PhD in relevant discipline (eg, chemical engineering, biochemical engineering, chemistry or related field) or commensurate years of education and experience

Experience in biologics drug product process development and aseptic manufacturing required

Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations

Proven track record of advancing assets from pre-clinical through IND and into late phase development

Extensive experience with cGMPs and knowledge of regulatory guidance

Experience with formulation development of recombinant proteins, including antibodies

Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, Quality, and Regulatory

Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams

Availability to participate in calls across multiple international time zones

Ability and willingness to travel up to 25%, including frequently to the Apogee lab in Boston

Preferred

Experience with commercialization of biologics

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

Flexible PTO

Two, one-week company-wide shutdowns each year

Commitment to growing you professionally and providing access to resources to further your development

Apogee offers regular all team, in-person meetings to build relationships and problem solve