Senior Director or Vice President of CMC
Escient is seeking an outstanding leader with a background in Chemistry Manufacturing and Controls (CMC) who has extensive experience in manufacturing and advancing small molecules through clinical trials to approval. The ideal candidate is one who has been involved in all aspects of drug product (API) and drug substance (DS) manufacture and can direct and oversee CMC regulatory strategy for multiple products.
This role requires strategic leadership, the ability to provide guidance and support to quality and contract manufacturing, and ensuring all products are manufactured in compliance with applicable regulations. In addition, the ideal candidate will have experience on overseeing the preparation of CMC regulatory submissions and interaction with regulatory agencies.
Detailed Job Description
Based in San Diego, CA, Escient Pharmaceuticals is a start-up biotech company strategically focused on unleashing the therapeutic potential of a novel family of specific orphan GPCRs, Mas-Related G-Protein Receptors (Mrgprs), for a broad range of therapeutic indications. We will initially pursue drugs for neuro-immuno-inflammatory and pseudo-allergic or autoreactive diseases. Our diverse team at Escient shares a passion for discovering and developing therapies for underserved patients that will positively change the course of their health and well-being. In addition, we embrace a unique and highly sought-after culture of authenticity, open communication, transparency, integrity, mutual respect, and freedom to brainstorm and share one’s thoughts and ideas at every level.
Of immediate need to Escient is a Senior Director or Vice President of Chemical Manufacturing and Controls (CMC). The ideal candidate must be an outstanding leader with a proven track record of strategic planning and successful execution in advancing molecules from pre-clinical manufacturing to late-stage clinical trials. Experience with commercial drug substance and drug product manufacturing is highly desirable.
The candidate must be a seasoned in all aspects of DP and DS manufacture. This includes the selection and management CROs, execution of API under cGxP conditions, development of formulation strategies, and implementation of analytical methods consistent with regulatory guidelines.
This role involves strategic oversight in anticipating drug supply needs for both preclinical and clinical studies, along with managing supply chain and logistics in support of multiple clinical trials.
In addition, the role requires authoring, reviewing and editing GMP batch records, IND documents, regulatory submission sections, and quality documents. The successful candidate will execute plans for the release, validation and registration of API and DP as required by regulatory and ICH guidelines.
The candidate must have strong organizational and communication skills, be capable of strategically communicating to upper management, summarizing data, and effectively communicating across functions. Finally, the candidate must be comfortable with, and thrive in, a fast-paced entrepreneurial environment which necessitates a hands-on approach at all levels.
Responsibilities include the following:
- Strategic oversight and execution in manufacturing API and DS for all stages of clinical trials. Experience with commercial drug substance and drug product manufacturing is highly desirable.
- Selection and management CROs who can deliver robust, scalable and cost-effective manufacturing routes for API manufacturing
- Design and develop formulations that meet target product profile for the clinic
- Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
- Anticipating drug supply needs for both preclinical and clinical studies, along with managing supply chain, drug labeling and logistics in support of multiple clinical trials
- Be proficient in the latest regulatory guidelines. Author, review and edit batch records, IND documents, regulatory submission sections, and quality documents.
- Work effectively in a fast-paced, multi-disciplinary setting of chemistry, biology, pharmacology, preclinical studies supported by external CROs;
- Aid in fostering a culture of authenticity, open communication, transparency, integrity, mutual respect, and freedom to brainstorm and share thoughts and ideas;
- Communicate effectively within project teams and work to progress against goals in a multidisciplinary setting;
- Perform other related duties as required.
Qualifications include the following:
- PhD or MS in Pharmaceutical Chemistry, Organic Chemistry, Analytical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
- 10+ years of experience in a pharmaceutical or biotechnology CMC/GMP environment and experience in small molecule manufacturing
- Experience in managing International CRO/CMOs for the manufacture of GMP APIs and DP. Experience in supply chain management would be a plus.
- Experience with IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations and guidelines
- Proven track record of strong cross-functional skills, interacting effectively both internally and externally
- Demonstrated record of success as evidenced by progression of multiple drug candidates into clinical trials
- Computer Skills: Advance knowledge of Excel, Word, PowerPoint and Graphpad prism;
- Alignment with the company’s culture; and
- Core Competencies:
- Ability to thrive in a fast-paced, hands-on research and development environment;
- Effective at planning, organizing, and prioritizing;
- Able to handle multiple tasks and deliver high quality results under tight timelines;
- High attention to detail and accuracy;
- Effective troubleshooting and problem-solving skills;
- Flexible and adaptable to change;
- Adept at building strong relationships and collaborating with colleagues at all levels;
- Effective team player and strong individual contributor;
- Highly collaborative, self-motivated, and team-oriented; and
- Effective communicator in both oral and written form.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly be required to use his/her hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. The employee will regularly be required to sit, stand, walk, talk and hear; use hands to handle or feel; see computer screens and read printouts; and reach with arms and hands. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus. The employee needs to be able to stand for long periods of time in a laboratory setting including in front of a hood and at the bench. As well, s/he may occasionally be required to lift up to 50 pounds.
If you thrive in a fast-paced, entrepreneurial environment and are in search of a dynamic, multi-disciplinary team focused on discovering and developing therapies that will positively change the course of the health and well-being of underserved patients, we encourage you to apply. Escient Pharmaceuticals offers a positive and exciting work environment with competitive pay structures and benefits. Escient is an equal opportunity employer.