Reporting to the Vice President, CMC and QA, this role is key to progressing client’s programs to clinical development. The successful candidate will be a hands-on leader working cross-functionally to support delivery of client’s goals for initiation and delivery of clinical development programs. The successful candidate must have a ‘can do’ attitude and be able to work independently but also be an effective partner and communicator in a matrix organization involving colleagues across R&D and many CRO/CMO partners. The candidate will be responsible for a variety of activities including but not limited to the following:

RESPONSIBILITIES:

• Oversight of CMC vendors, including adherence to quality, budget and timeline metrics.
• Collaboration with internal team and external partners and vendors to ensure integrated and quality driven production of drug substance to enable FIH (First In Human) regulatory packages and subsequent clinical studies.
• Proactive identification, communication, and appropriate mitigation of key CMC risks.
• Authoring of key elements of CMC regulatory documents and responses.

 QUALIFICATIONS:

• Advanced scientific degree with at least 8-10 years of CMC experience in the biopharma industry.
• Strong scientific and technical track record in small molecule product development (drug substance process development, scale up, manufacturing and analytical testing).
• Demonstrated experience of management/oversight of CGMP activities (including technical review of master and executed batch records, oversight of manufacturing activities).
• Experience of management of contract development and manufacturing organizations.
• Familiarity with requirements for regulatory submissions in major global regions.
• Attention to detail, critical analysis of data/reports, and troubleshooting/root cause analysis abilities.
• Ability to adapt to and effectively manage change in a fast paced, lean, dynamic environment
• Outstanding verbal and written communication skills and strong organizational skills.
• This role is hybrid offering lots of flexibility and located in the Boston Seaport area