The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site and virtual-office scenarios
- Clients include a range of biotech start-ups to multinational pharmaceutical companies
Syner-G Pharma, CMC Consulting is seeking an exceptional candidate to join our team as our Associate Director/Director in our technical vertical. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients across all stages of development, including serving as the client lead to support preclinical development, as well as management of CTM manufacturing of CMOs in North America, Asia and Europe. The Dynamic Associate Director or Director will report to the Vice President of Technical CMC Development.
Responsibilities and Duties
- Guide the selection of phase appropriate formulations for client lead compounds to provide adequate clinical exposure.
- Plan/execute all activities related to the development and manufacturing oversight of small molecule oral dosage formulations.
- Manage multiple CROs and CMOs during various phases of pharmaceutical development and drug product manufacturing, GLP and GMP, for small molecules.
- Oversee and manage technical drug product manufacturing and process transfer activities, manufacturing process scale-up and CTM manufacturing campaigns.
- Review/approve of master and executed batch records.
- Author/review DS/DP related CMC sections for IND/CTA/IMPD/NDA regulatory filings.
- Provide CMC technical due diligence to support business development/in-licensing efforts for clients.
- Establish and maintain effective working relationships with key internal and external stakeholders.
Required Skills and Experience:
- PhD in pharmaceutics, chemical engineering or material sciences with 6+ years or MS degree with 9+ years as a team member of various drug development programs.
- Skilled in managing relationships with CROs, CMOs and testing labs.
- Knowledge of small molecule and solid oral dosage forms.
- Experienced in late stage program development including registration stability and process validation strategies.
- Excellent communication skills, both written and verbal.
- Comprehensive understanding of the drug product formulation process, quality, and regulatory development.
- Comprehensive understanding of the physical and chemical characterization of molecules, including solid state and solution properties.
- Versed in technologies to enhance poorly soluble and/or bioavailable candidates and the physical and chemical characterization of molecules.
- Experienced in developing enabled formulations for solid oral dosage forms.
- Ability to effectively prioritize and manage multiple projects and tasks.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely, and consistent manner