The CMC leader will build and lead a group responsible for CMC-related activities across the portfolio including scale up efforts during lead optimization to support preclinical activities, process chemistry and route development, chemical manufacturing, pre-formulation, formulation and manufacture and supply of clinical trial materials. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

 

Responsibilities:

• Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies
• Identification, selection, and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs
• Develop and implement strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs or in support of internal manufacturing
• Delivery of robust, scalable, and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
• Transfer processes and technologies to manufacturing (internal or external)
• Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team)
• Formulation design/development for clinical programs
• Management of supply chain and logistics in support of clinical studies
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
• Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
• Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities
• Prepare, review, or edit cGMP batch records, CMC regulatory and Quality documents
• Prepare technical reports, publications, and oral presentations

 

Experience:

• PhD or MS ; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• 10+  years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
• 5+ years in a progressive leadership role
• Substantial experience in managing US and International CRO/CMOs for the manufacture of cGMP oligonucleotide APIs and DP
• Substantial experience with projects in clinical development e.g., Phase 1 through Phase 3
• Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
• Experience in supply chain management
• Able to identify and resolve critical issues
• Experience implementing technical, strategic, and operational plans
• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
• Qualities of servant leadership and self-awareness required

Work Environment:

This will be a laboratory and office-based position that will require some non-standard working hours including early morning or later evening teleconferences to support global company programs.

Physical Demands:

• Employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• The employee will be required to communicate using telephone and e-mail.

Sirius Therapeutics is an equal opportunity employer.