Associate Director, Drug Product

IMVT Corporation; Poland; Remote; PLN 675,000 - 712,000; Full time

Job summary

A clinical-stage immunology company is seeking an Associate for Direct Drug Product Development. The successful candidate will lead process design and oversee drug product activities, requiring extensive experience in biologics. This role offers a competitive salary range of $185,000 - $195,000 USD, along with extensive benefits and a remote-based working environment.

Benefits

Unlimited paid time off

Parental leave

Comprehensive medical benefits

Qualifications

• Experience with late-stage commercialization of biologics drug-device programs.
• Working knowledge of regulatory requirements for commercialization.
• Experience with drug product unit operations of manufacturing.

Responsibilities

• Lead drug product process design and robust commercial validation.
• Serve on cross-functional DP work streams and manage DP activities.
• Provide technical oversight and guide the team on scientific issues.
• Work closely with CMC regulatory team and manage regulatory submissions.

Skills

Drug product process development

Process characterization

Regulatory submissions

Effective communication skills

Understanding of protein and process science

Education

B.S. in Chemical Engineering or related field with 10+ years experience

Advanced degree in related field with 5+ years experience

Job description

Overview

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

Associate, Direct, Drug Product Development. This individual will report to the Executive Director and will be responsible for supporting ongoing drug product formulation and manufacturing at our CMO partners. This role is a key contributor within the CMC organization, with experience advancing and commercializing biologic drug product programs. The incumbent will be responsible for late-stage commercialization activities of a biologic drug-device product including process scale-up, technology transfer to external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.

As a member of the drug product team, the candidate will focus on driving excellence in process characterization, scale-up, transfer, process validation activities and regulatory filing (IND, IMPD, BLA and MAA).

Key Responsibilities

• Lead and provide oversight to drug product (DP) process design, including characterization, technology transfer, and robust commercial validation
• Serve on cross-functional DP work streams and manage DP activities and documents (reviewing/authoring reports, and protocols) through Process Performance Qualification (PPQ), including registration stability study execution, process characterization planning and execution, tech transfer strategy, PPQ readiness, regulatory filings, PAI (Pre-Approval Inspection) readiness, approval, and launch support
• Provide technical oversight and use experience gained on scientific/technical issues to guide the team to investigate and close out deviations in timely manner to enable release of manufactured DP batches
• Ensure integration of primary filled container closure and component specifications and testing with the combination product design
• Work closely with CMC regulatory team and be accountable for DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparations for agency meetings. Author and review regulatory submissions
• Effectively/efficiently manage CDMOs and deliver success on drug product supply and BLA filing readiness

Qualifications

• B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Biochemistry, Microbiology, or related field with ten (10) or more years of relevant experience; OR
• Advanced degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience

Required Experience and Skills:

• Experience with drug product process development, process characterization, technology transfer and scale-up of processes to manufacturing scales of biologics (mAbs or fusion proteins)
• Experience with drug product unit operations of manufacturing including freeze/thaw, mixing, filtration, filling and inspection of prefilled syringes
• Working knowledge of regulatory requirements for commercialization including application of Quality by Design principles
• Working understanding of analytical methods to characterize biologics
• Experience with late-stage commercialization of biologics drug-device programs through PPQ and launch
• Effective oral and written communication skills. Ability to effectively author or review technical reports, CMC/CTD sections for IND/IMPD, BLA/MAA filings
• Ability to effectively articulate understanding of protein and process science to drive decision making on investigations of deviations, impact assessments, design of studies, etc., in a multi-disciplinary team-matrix environment
• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Travel up to 25% (domestic or international)

Compensation

Salary range for posting: $185,000 - $195,000 USD

Compensation is based on factors including market location and may vary by job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, along with a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

Note: This description only reflects the professional responsibilities and qualifications for the role. This posting may include legal requirements and protections such as EEO statements which remain in scope as applicable.