Position Overview: The Associate Director of Analytical and Research Development will report to the Head of Chemistry and will be part of the CMC team. In this role, they will lead both non-GMP and GMP activities requiring analytical chemistry input for all IND and clinical small molecule projects.
- The ideal candidate will provide analytical method development, validation and transfer for drug substances, drug products, GMP starting materials, intermediates, in-process controls to enable clinical and commercial manufacturing.
- Provide direction, oversight and technical expertise for analytical activities, play a key role in troubleshooting and change management at external CMO/CROs.
- Author and review cGMP batch records, regulatory inquiries, investigation reports and sections of CMC (chemistry and manufacturing control) documents.
- Work under cGMP, FDA and ICH guidelines and regulations.
- Support process development, scale-up, technology transfer, manufacturing campaigns, and collaborated effectively with stakeholders.
- Oversee analytical related activities including method development, validation, method transfer, and in-process support of the API manufacturing, drug product development and generation of analytical methods.
- Use professional concepts and company’s policies and procedures to solve a wide range of difficult and complex problems in imaginative and practical ways.
- Apply a science-driven, phase-appropriate and risk-based analytical development strategy to support projects from IND to clinical development to commercial production.
- Author regulatory dossiers and development reports. They must have the ability to work independently and as an effective and engaged team member in a fast-paced
- Be responsible for GMP related activities such as DS/DP release, stability testing, OOT/OOS investigation support, and issuance and maintenance of specifications.
- Manage analytical and quality control activities at CROs/CMOs to support release, stability testing, data integrity, and development activities.
- Author, review, and/or approve analytical and QC sections of regulatory submissions, SOPs, STMs, specifications, protocols, reports, OOT/OOS investigations and other controlled documents as needed.
- Responsible for strategic planning and obtaining cross functional alignment to enable project success.
- Evaluate and implement new processes, best practices, and technologies through awareness of industry and regulatory trends.
- Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Ensure all QC procedures follow FDA/EMA guidelines and internal/CMO SOPs
- Oversee release testing of all raw materials, intermediates, APIs and DPs
- Manage inventory and distribution of reference standards through external partners
- Interface with other functions, such as Process Chemistry, Contract Manufacturing, Pharmaceutical Technology, Quality Assurance, Regulatory, Clinical Pharmacology, Clinical Sciences, Supply Chain, Early Development, and Project Management
- Perform other duties as assigned using Core Competencies, Knowledge and Skill
- Supervise a BS/MS analytical chemist
- Thorough understanding of pharmaceutical and analytical development of small molecules
- In-depth knowledge and hands-on experience with HPLC, GC, MS, and compendial method development and testing
- Ability to interpret and apply cGMPs, USP/EP standards, ICH guidelines and industry best practices
- Proven experience in handling confidential and sensitive information with the ability to exercise discretion and show good judgment
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work independently.
- Daily demonstrates a positive, ‘can do’ and service oriented attitude with a commitment to detail
- Strong oral and written communicator
- Self-motivated to take ownership of and follow through with tasks
- Ability to balance competing priorities and triage to pivot quickly to meet tight deadlines
- Skilled in developing collaborative internal and external relationships
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint), quality systems (e.g. TrackWise), and statistical software (e.g. JMP)
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Capable of driving decisions through well designed, effective presentations
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- PhD degree in Analytical Chemistry in Analytical Chemistry with extensive industry experience.
- Requires 7+ years of progressive experience in the biopharmaceutical/biotech industry, GMP environment.
- Knowledge of modern pharmaceutical practices and techniques with a solid scientific understanding of drug development process. Experience with solid dosage formulation development and manufacturing is a requirement.
- Significant experience working in an outsourcing environment as well as internal laboratories.
- A strong track record of scientific achievements including external publications and presentations.
- Prior experience in developing fixed-dose combination is highly desired.
- Demonstrated problem solving skills, strategic thinking, and proven leadership
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds