Director, Analytical Development
The Director, Analytical Development will be a leader of the analytical development team and he/she will lead and manage activities of analytical development, validation and characterization of drug substances and drug products conducted in a virtual operating environment working with various CTLs. While managing and developing a team of scientists, the candidate will be responsible for biologics methods development, optimization, and validation and that these activities are phase appropriate and consistent with regulatory guidance. For pipeline projects, the candidate will provide analytical leadership in designing and developing an appropriate analytical control strategy using variety of methods, establish product specifications, and establish appropriate stability programs. The individual will lead the development of biologics appropriate methods for all phases of manufacture from raw materials, in-process, release, as well as, for stability testing. Individual will also lead activities for further understanding of drug substance and drug product biochemical and physical properties, as well as, as their changes as impacted by manufacturing process and/or interactions with excipients and container components. The candidate and his/her team will be also responsible for various regulatory contributions: regulatory submissions (modules of IND, BLA, MAA) and regulatory support (agency requests). In all of these responsibilities, the individual will lead a team consisting of scientists, as well, as, consultants/contractors, as required, and/or cross-functional team members. The candidate will select, establish, and manage appropriate CTLs for all of these activities. The candidate will work closely with the cross-leadership from Quality Control, Manufacturing/Supply Chain, Quality Assurance, Project Management, to Regulatory Affairs to ensure timely deliverables/goals completion and execution consistent with budget. The candidate will be responsible and lead the strategic vision for analytical development function with developing plans for organization growth, adoption of new technologies, platforms, systems, and for budget planning.
For all pipeline clinical programs, oversee all activities associated with analytical development, validation, and characterization of biopharmaceutical products at Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs). Contributing to regulatory filings (MAA, IND), as well as, regulatory responses.
Review and/or approve analytical development, method validation/verification protocols/reports and analytical technical reports. Manage CLT for effective delivery analytical activities (method development, validation), analytical characterization studies (comparability, drug substance properties, forced degradation), and analytical data for manufacturing studies (e.g. development stability, process changes). Ensure compliance of Aimmune analytical testing activities with applicable compendia (e.g., USP, NF, EP) and regulatory guidance documents. Work collaboratively with manufacturing/supply chain, quality assurance, regulatory affairs, and project management to ensure timely completion of activities.
Qualifications / Requirements:
Education and/or experience:
- Advanced degree (M.S., Ph.D. preferred) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10-12 years relevant professional experience in a combination of analytical development and/or quality control in biopharmaceuticals.
- Previous management and mentoring experience of scientific staff is required.
- Experience managing contract testing laboratories or other external laboratories for analytical development, validation, and characterization studies is required.
- Experience in leading the development of analytical control strategy and stability studies for clinical development program is required.
- For clinical development programs, managing IND-enabling studies, directing completion of CMC analytical modules, and responding to regulatory requests is required from US and global regulatory agencies.
- Understanding of global regulatory requirements for pharmaceutical products, as well as, ICH and other guidelines is needed.
- Experience with analytical method development and validation for support of testing of raw materials, in-process, release, stability testing to determine various attributes (purity, content, impurities, identity, etc.) is required.
- Experience in product characterization using biophysical, spectroscopic, functional, chromatographic, electrophoretic, or immune methods is required.
- Experience with compendial or general chemistry methods for product testing is required.
- Prior experience in evaluating and implement of new technologies to meet product characterization and testing requirements is preferred.
- Experience with critical reagents (antibody development and characterization) for bioassays is preferred.
- Experience with statistical methods and software tools is preferred.
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents (US and EU) as they relate to quality release and stability testing of biopharmaceutical products is required.
- Ability to travel up to 10% of the time.
- Ability to effectively prioritize and deliver high-quality results on tight timelines and budgets
- Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment
- Excellent written and verbal communication skills
- Accuracy and attention to detail
- Excellent cross-functional team participation skills
- Outstanding problem solving skills including the ability to devise and implement practical solutions to resolve complex issues in a virtual environment
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.