Director, Formulation Development, Tech Ops (Biologics)

Job Title:  Director, Formulation Development, Tech Ops (Biologics)        

Location: Hybrid or Remote - Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week.            

Role Overview:

The Director of Formulation Development will provide scientific and strategic leadership for early- and late-stage formulation development activities supporting phase-appropriate formulations of biologic drug products, with a focus on monoclonal antibodies, bispecific formats, and co-formulations. This role will lead formulation development and container closure selection, and partner with the Drug Product team to support process development studies across early- and late-stage development. The position will support BLA/MAA submissions, formulation changes, and commercial readiness, while partnering closely with CMC, Quality, Regulatory Affairs, and external partners.

The ideal candidate is a hands-on leader with deep expertise in formulation development for complex biologics, spanning early through late-stage development, with a focus on commercial readiness. This role is highly visible within the CMC team and a pivotal addition to our growing organization where you will play an integral role in supporting multiple programs’ formulation activities for clinical trials and preparing for commercialization across the US, Canada, and EU.

Key Responsibilities: 

• Lead phase-appropriate formulation development workflows for biologics, including selection, optimization, and robustness studies, with a focus on high concentration product development.
• Experience with co-formulation products.
• Experience with PFS and Autoinjector selection and testing.
• Partner with drug product and clinical teams to ensure appropriate container closure selections are made that align with QTPP and clinical needs.
• Design and execute in-use compatibility studies to support subcutaneous administration of high concentration biologics.
• Partner with analytical development to verify that assays are not impacted by formulation changes.
• Drive formulation strategies to support robustness and comparability studies, BLA/MAA submissions, and post-approval changes.
• Partner with Process Development, Manufacturing, Quality, and Regulatory to support late-stage development, tech transfer, and commercial launch readiness.
• Support formulation risk assessments, control strategy development, and lifecycle management activities.
• Serve as formulation lead for regulatory interactions, including agency questions and inspections.
• Build, mentor, and lead a high-performing formulation development team (internal and/or external).
• Set technical direction, priorities, and timelines for late-stage formulation deliverables.
• Manage and provide technical oversight to CDMOs and contract laboratories.
• Review and approve formulation development protocols, development reports, and regulatory documentation.
• Up to 20% travel is required for this role.

Qualifications:

• Experience with monoclonal antibodies (both monotherapy and co-formulation) is a requirement.
• Experience with PFS/Autoinjector selection studies is a requirement.
• Director: Master’s (10+ years) or PhD (7+ years) in a scientific discipline with relevant experience in formulation development and/or drug product development.
• Relevant industry experience in phase-appropriate formulation development and container closure selection studies.
• Experience supporting drug product process development studies is a plus.
• Experience with methods including but not limited to U/HPLC, Capillary Electrophoresis, Spectrophotometry, Bioassay (ELISA and Cell-Based), and device functional testing.
• Experience with formulation robustness studies in support of PC/PPQ and commercialization is required.
• Experience with late-phase comparability studies, especially geared toward commercialization.
• Experience in authoring/contributing to regulatory filings, specifically Module 3 for formulation development and stability studies.
• Demonstrated track record of successful tech transfers between CDMOs with an eye toward late-stage development and commercial launch.
• Excellent writing, organization, communication, and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders.
• Must have a creative and strategic mindset with the ability to work in a fast-paced environment.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA or Remotely is $213,000 to $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.