Director/Sr. Director - Process Chemistry (CMC-1025)
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.
- Lead and manage all technical aspects of drug substance development, scale-up, and manufacturing at select CRO/CDMO around the world
- Conduct process development studies at CDMOs according to the principles of quality by design (QbD), perform specification justification studies to establish limits, perform process characterization studies such as design of experiment (DOE) studies and one variable at a time (OVAT) to identify proven acceptable ranges (PARs) to establish critical process parameters (CPPs), and characterization of API to identify critical process parameters
- Oversee GMP manufacturing of drug substance at CDMOs and possess a strong understanding of cGMP’s, as well as firm understanding of regulatory guidance from the ICH, FDA, EU and Japan
- Design chemical development strategy that is phase appropriate and well positioned for accelerated development, and design and execution of validation master plan 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 molecule or bachelor's degree in Chemistry or related discipline with 8-10 years of experience in Process Chemistry of small molecules is required.
- Excellent written and oral communication skills, the ability to effectively influence the work of others.
- General knowledge of drug development and the pharmaceutical industry are key.
- In-depth understanding and working knowledge of organic chemistry, process chemistry, engineering scale-up principles and experimental design, as well as significant experience applying this toward development of API manufacturing processes.
- A thorough understanding of statistical analysis principles used in Design of Experiments to efficiently plan process development, optimization, and characterization studies to provide statistically meaningful outputs and direction for future studies and final processes.
- Extensive work experience with CDMOs/CROs.
- A strong working knowledge of current Good Manufacturing Processes (cGMP) .
- Experience with Quality and Regulatory environment is important.
- Prepares 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.
- Works collaboratively across internal stakeholder functions such as Project Management, Manufacturing Operations Clinical and Regulatory to meet program goals, including representation on CMC development teams.
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-1025 number in the subject.
* AN2 Therapeutics is based in Menlo Park, CA, but employees are currently working remotely due to the COVID-19 pandemic.