Director/Sr. Director - Process Chemistry (CH-1036)
AN2 Therapeutics, Inc. (AN2) is a biopharmaceutical company focused on developing novel anti-infective medicines for patients with rare, chronic infectious diseases – including global and neglected tropical diseases – that have significant unmet medical needs for new therapies. Founded by a team of experienced industry leaders in infectious diseases 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 a Director/Sr. Director – Process Chemistry. This position will currently report to the VP, Process Chemistry.
- Lead and manage all technical aspects of drug substance development, scale-up, and manufacturing at select CRO/CDMOs around the world
- Design an overarching chemical development strategy that is phase appropriate and well positioned to enable accelerated development
- Manage all chemical development activities at CDMOs including:
- CDCO selection and initial technical transfer
- Route scouting, process development and initial scale up
- Process optimization studies to ensure robustness at each scale of operation
- Pre-validation activities such as specification justification studies to establish limits, DOE and OVAT studies to identify proven acceptable ranges (PARs) and establish critical process parameters (CPPs)
- Oversee all aspects of manufacturing of drug substance at CDMOs and ensure compliance with cGMPs as appropriate
- Assist in design and execution of validation master plans to support commercialization
- Work closely with the cross-functional teams to develop the API supply strategy and manage aggressive project timelines
- Communicate scientific results (oral and written) in a clear and concise manner within cross-functional teams
- Author appropriate Quality sections for regulatory submissions (IND, IMPD, and/or NDA)
Qualifications and Experience:
- M.S or PhD. in Chemistry/Chemical Engineering or related discipline with 3-6 years of pharmaceutical R&D experience in Process Chemistry of small molecules or Bachelor's degree in Chemistry or related discipline with 8-10 years of experience in Process Chemistry of small molecules is required.
- In-depth understanding and working knowledge of process chemistry, engineering scale-up principles and experimental design, as well as significant experience applying this toward development of API manufacturing processes
- Extensive experience managing outsourced work at CDMOs/CROs
- A strong working knowledge of current Good Manufacturing Practice (cGMP)
- Firm understanding of regulatory guidance from the ICH, FDA, EU and Japan
- Direct experience in preparation of development reports and other technical documentation required for regulatory submissions including authoring, review and approval of requisite sections of the IND, CTA, IMPD, NDA, MAA or other filings
- Proven ability to work collaboratively with internal stakeholder functions such as Project Management, Manufacturing Operations Clinical and Regulatory to meet program goals, including representation on CMC development teams
- Excellent written and oral communication skills, the ability to effectively influence the work of others
- Solid understanding of drug development and regulatory compliance within as related to small molecules is key
- Familiarity with analytical techniques and methods used to characterize small molecule APIs
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 CH-1036 number in the subject.
* AN2 Therapeutics is based in Menlo Park, CA, and employees are currently working a hybrid schedule due to the COVID-19 pandemic.