JOB DESCRIPTION

We are seeking an Associate Director/ Director, CMC, Analytical Development to join our CMC team. This person will be responsible for the development of analytical methodology and characterization activities in support of new drug substances and new drug product development and manufacturing. They will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (including GLP and cGMP). They will provide analytical support for drug substance and drug product manufacturing in support of preclinical, clinical, registrational, validation, and commercial batches as well as preparation of CMC sections for regulatory submissions and updates. This role will report to the SVP, Head of CMC. 

Volastra is a fast-paced biotech company of passionate employees, and there is substantial opportunity for the ideal candidate to grow and develop with the organization.  Individuals will have the opportunity to work on projects and take on responsibilities that may fall outside their immediate scope of work.   

The job is based in NYC with a flexible option for hybrid work.  

RESPONSIBILITIES

• Work with cross-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard qualification, and product characterization. 
• Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products, both internally and across Volastra’s network of CDMOs. 
• Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing. 
• Provide detailed review and approve protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification
• Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external Quality Control, Quality Assurance, and Regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.  
• Collaborate closely with Quality Control and Quality Assurance to ensure the timely GMP release of drug substance and drug product lots.  
• Author/review technical documents outlining analytical activities including method validation, method transfer, reference standard and impurity characterization, stability, etc. 
• Maintain current knowledge of issues relevant to drug development, Competent Authority regulations and guidance, as well as industry trends. 
• Plan and manage budget proposals in accordance with the Company’s strategic operating plans and Finance policies. 
• Contribute to continuous improvement of project workflows, communication tools, and documentation practices 
• Ability to travel up to 25% domestically and internationally. 

QUALIFICATIONS

• Ph.D. with 7+ years or M.Sc. with 10+ years of experience in analytical chemistry or a closely related field with directly related industry experience.  
• Experience with analytical development of small molecules and solid oral dosage forms in various stages of development 
• In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), the identification of impurities and degradation products, and reference standard qualification.  
• Demonstrated knowledge of drug development, CDMO management, manufacturing, and regulatory CMC. Extensive knowledge of cGMP-related regulations, guidance, principles and best practices pertinent to the testing of both drug substances and drug products in both development and commercial contexts. . 
• Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices 
• Experience preparing and updating regulatory filings (IND, IMPD, CTA, NDA, MAA) 
• Experience managing projects and FTEs at GMP testing CROs.
• Ability to effectively organize and prioritize tasks to achieve established deadlines 
• Strong communication and interpersonal skills, with the ability to build effective working relationships and foster trust across teams and with external partners. 

SALARY RANGE

Approximately $160,000 - $210,000 which may vary depending on qualifications, experience, and ultimate leveling.