Associate Director/Director, Analytical Development & Quality Control (CMC-1041)
AN2 Therapeutics (AN2) is a biopharmaceutical company focused on developing novel medicines for patients with rare, orphan infectious diseases that represent significant unmet needs. Founded by a team of experienced industry leaders in infectious disease drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission.
AN2 is seeking an experienced Associate Director/Director of Analytical Development & Quality Control to support the development of its investigational drug programs. The individual will play an essential role in cross-functional teams and will be responsible for supporting/driving CMC activities related to analytical development for both API and drug products. This position will report to the Senior Director of Analytical Chemistry. This is not a lab position.
- Ensures all analytical development & stability activities for both drug substance and drug product are aligned with AN2’s project goals and timelines.
- Works collaboratively with internal stakeholder functions such as Project Management, QA, Clinical, and Regulatory to meet program goals. Represents CMC on development teams. Coordinates seamlessly with CMC colleagues overseeing drug substance and drug product activities.
- Manages stability programs at various external vendors including protocol design and specifications, and data review, trending, and analysis. Ensures stability studies support clinical development and regulatory objectives & timelines.
- Review and QC of batch record analytical data packages; provide technical input toward batch release.
- Manages analytical development related activities at external vendors, including oversight of method development & validation, and stability programs.
- Reviews analytical related technical documents, including method development reports, method validation protocols & reports, test methods, and specifications.
- Takes an active role and applies subject matter expertise in establishing phase- appropriate analytical methods & validation, and release & shelf-life specifications.
- Oversees qualification of reference materials and management of their inventory & supply across testing sites.
- Oversees CMO analytical deviation & event investigations, and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.
- Ensures that all work is conducted in accordance with applicable policies and procedures, CGMP, and regulatory standards & guidelines. Maintains an understanding of global laws & regulations applicable to the pharmaceutical industry.
- Prepares pharmaceutical development reports and other technical documentation required for regulatory submissions including authoring, review, and approval of the requisite sections of IND, CTA, IMPD, NDA, MAA or other filings.
- Assists in the responses to health authority questions.
- Leads and participates in initiatives for improving functional processes and technical operations within CMC.
Qualifications and Experience:
- PhD, MS or BS in Analytical Chemistry or related discipline with at least 10 years of experience working in CMC/Analytical development in the pharmaceutical industry; or equivalent.
- Expertise in a wide variety of analytical methodology and instrumentation used in the testing and characterization of raw materials, excipients, drug substances, and drug products.
- Extensive experience in small-molecule NCE drugs, particularly in their solid oral and parenteral dosage forms.
- Successful leadership of analytical method development & validation, production QC, and stability program activities.
- Expertise in impurity/degradant identification and coordinating qualification with non-clinical colleagues.
- Demonstrated experience driving these CMC activities in a virtual pharma business setting through management of external partners and CRO/CMOs.
- Excellent awareness & understanding of other stakeholder roles in CMC, and analytical development's relationship to them.
- Excellent working knowledge of CGMP, regulatory guidance, and compendial requirements, including FDA, EMA, ICH, WHO, USP-NF and EP.
- Excellent technical writing, oral, presentation, and interpersonal communication skills.
- Excellent data presentation & analysis skills, including the creation of publication quality tables & graphs.
- Fluent in the Microsoft ecosystem, including Office & SharePoint, and PDF publication & editing software such as Adobe Acrobat. Comfortable with electronic records & digital workflows.
- Possesses high integrity and exceptional work ethic.
- Must be flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. Exceptional problem-solving skills.
- Team oriented; ability to work collaboratively with internal colleagues and vendors.
- Understands and anticipates the impact of business and commercial needs on advanced- stage drug development. Distinguishes research from development.
- Some travel is required, including both domestic and international.
AN2 anticipates that the annual base salary for this position could range from between $175,000 to $230,000 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. Compensation decisions are dependent on the facts and circumstances of each case. The successful candidate will also be eligible to participate in a performance-based bonus and stock programs, various benefits offerings, including, but not limited to, medical, dental and vision insurance, disability, life insurance, 401k retirement savings plan, and flexible paid vacation.
By joining our small, highly dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy – with the intention of a fiscal and social return - this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.
We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.
Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees.
Please send your resume to careers@AN2Therapeutics.com and include the job title and CMC-1041 number in the subject.
* AN2 Therapeutics is based in Menlo Park, CA, and employees are currently working a hybrid schedule.