Director / Sr. Director, Manufacturing Sciences

Role Overview

Angitia Biopharmaceuticals is hiring a Director / Sr. Director in Manufacturing Science and CMC Operations to help connect drug substance process development, analytical development, and external manufacturing partners across the later stages of development for bispecific monoclonal antibody programs.

The company follows a fully outsourced operating model, so this position centers on sponsor-side oversight of CDMO activities, bringing together process and analytical information, managing documentation, and supporting manufacturing readiness. The successful candidate will provide technical leadership for drug substance activities, oversee CDMO execution on a day-to-day basis, and help drive programs toward Phase 3 readiness, process validation, and commercial supply.

This position sits within a lean US-based CMC organization and works closely with Process Development, Analytical Development, Program Management, Quality, and Regulatory CMC. It is best suited to someone who can bring strong late-stage development and validation discipline while remaining effective in a small, evolving environment where practical judgment and ownership matter.

Position Details

Department: CMC

Location: Remote, with up to 20% global and domestic travel

Reporting line: VP, CMC Operations

Responsibilities

• Act as the sponsor-side technical contact for drug substance manufacturing performed at CDMO sites and provide oversight throughout execution.
• Be present on site when needed during critical manufacturing milestones, including engineering runs, process performance qualification activities, and implementation of process changes.
• Assess batch records, in-process results, deviations, and investigations from the sponsor perspective, and support technical input for deviations, CAPAs, and change controls.
• Build and manage a continued process verification and process monitoring program to trend process and analytical data across campaigns and evaluate consistency, robustness, and comparability.
• Spot improvement opportunities based on monitoring results and manufacturing learnings, and work with Process Development to advance them.
• Maintain alignment, consistency, and quality across the CMC document package, including Module 3 content for INDs, CTAs, and IMPD updates, while reviewing CDMO-authored material.
• Review technical documents from CDMOs such as tech transfer plans, reports, and process validation files, and turn them into clear and defensible regulatory content.
• Prepare and finalize responses to health authority questions and information requests related to CMC topics.
• Ensure that scientific content and regulatory positioning remain accurate and consistent across all CMC materials for both programs.
• Coordinate technology transfer work as Phase 3 processes are defined and implemented at manufacturing partners.
• Support manufacturing readiness and process performance qualification planning, and write or contribute to PPQ protocols and reports from the sponsor side.
• Plan, execute, and interpret process and analytical comparability assessments as drug substance processes move across sites and scales, supporting the bridge from clinical material to Phase 3 and commercial supply.
• Contribute to control strategy development and justification of specifications for drug substance and drug product quality attributes in collaboration with Analytical Development and QC.
• Work across Process Development, Analytical Development, Program Management, Quality, and Regulatory CMC to advance key CMC deliverables.
• Support inspection readiness and submission readiness from a technical and documentation standpoint.

Qualifications

• Applicants should have experience with monoclonal antibodies or other complex biologics; experience with bispecific antibodies is a strong advantage.
• An advanced degree in biochemistry, chemistry, chemical or biochemical engineering, or a related life sciences field is preferred; a bachelor’s degree with extensive relevant industry experience may also be considered.
• Typically 10 to 12 years of biologics CMC development experience, including hands-on work in drug substance process development, analytical development, or manufacturing science/technical operations.
• Strong understanding of ICH requirements, especially Q6B, Q8, Q9, Q10, and Q11, along with GMP expectations for biologics.
• Working knowledge of control strategy concepts and specification setting for biological products.
• Strong technical judgment and the ability to manage external technical partners and influence cross-functional stakeholders without direct authority.
• Comfort working independently and making decisions in a lean, fast-moving organization.
• Ability to operate effectively in both structured late-stage/commercial environments and smaller, earlier-stage company settings.
• Willingness to travel to CDMO sites approximately 10% to 20% of the time; international travel is likely.

Preferred Background

• Experience in a fully outsourced, CDMO-driven development model.
• Prior MSAT or technical operations experience supporting late-stage or commercial biologics manufacturing.
• Background supporting BLA or MAA filings for biologics.
• Experience with PPQ and process validation in biologics manufacturing.

About Angitia Biopharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company founded in June 2018 and focused on developing innovative treatments for serious musculoskeletal diseases. The company is currently advancing three biologic candidates in the clinic for osteoporosis, osteogenesis imperfecta (OI), and spinal fusion.

With experienced scientific leadership and a team drawn from major multinational companies, Angitia combines advanced genetics, molecular biology, and computer-aided drug design to discover new targets and develop both biological and small-molecule medicines. The organization collaborates with academic and biopharmaceutical partners and is built around world-class scientists with deep expertise in musculoskeletal disease biology.

Angitia has offices in Westlake Village, California and Guangzhou, China, and is focused on delivering breakthrough therapies for unmet medical needs.

Compensation

The expected annual salary range for this position is $210,000 to $265,000.

Benefits

• Medical, dental, and vision insurance for employees and eligible dependents
• 401(k) retirement plan with company match
• Company-paid long-term disability coverage
• Company-paid life insurance and AD&D coverage
• Optional voluntary life insurance and AD&D coverage
• Employee Assistance Program (EAP)
• Company-paid holidays
• Vacation time
• Paid sick leave
• Monthly telecom stipend
• Work-from-home equipment reimbursement