Marinus Pharmaceuticals, Inc
Full Time
Remote, Remote, US
Professional
1155
Marinus Pharmaceuticals is a clinical stage biopharmaceutical company committed to developing breakthrough therapies to improve the quality of lives of patients and their families as they battle rare and life-threatening diseases.
Based in Radnor, PA we are comprised of a team of dedicated and talented professionals, valued for their innovation and commitment to developing new therapies for CNS disorders and their passion to make a positive difference in the lives of our patients.
We are currently searching for an experienced professional to join our team a
Director, Product Development.
Reporting to the Executive Director, Product Development, you will provide program management and leadership primarily to drug substance development, but also to drug product development projects spanning from early through post marketing life cycle management. Acting as the drug substance and chemistry champion for Marinus, you will provide technical expertise and support for CMC projects. You will also manage drug product activities from initial development through clinical studies and commercialization. This position will report to the Executive Director, Product Development.
Key responsibilities include but not limited to the following:
- Act as the drug substance champion. Manage, lead and provide technical leadership for CMC development activities of outsourced drug substance(s), including process development, scale-up and Commercial manufacture.
* Actively manage early and/or late phase drug substance activities at contract development laboratories and contract manufacturing organizations (including route selection, process development and optimization, scale-up and tech transfer)
* Provide guidance and assist in designing: fate and purge studies, PAR determination, QbD/DOE experiments, impurity ID, structure elucidation and process validation
* Implement control strategies for regulatory starting materials, intermediates, and API
* Collaborate internally with CMC (including drug product and analytical functions) as well as cross-functional teams (regulatory, quality)
- Provide technical expertise and support for drug product development and manufacturing activities including authoring, review and approval of protocols, batch records, technical reports, provide technical assessments, and development strategy.
- Provide technical expertise and develop responses for Regulatory CMC filings for submission to US FDA and International Regulatory Agencies.
- Represent the CMC team in cross-functional development teams as requested.
- Persuasive project management style when working with CMO/CRO to achieve company's business and technical objectives.
Education and Experience:
- Minimum Bachelors degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or closely related field. Masters degree preferred.
- Minimum 10+ years of progressive experience in drug substance and pharmaceutical development with strong knowledge of CMCs and general understanding of related functional areas
- Experience in drug substance development, formulation development, process development, clinical and commercial cGMP production including process validation experiments, preapproval inspections, and commercial manufacturing
- Hands-on experience and strong laboratory skills in organic synthesis of small molecules and multi-step synthetic processes preferred
- Knowledge of modern synthetic organic chemistry and rational molecule design, experience in asymmetric synthesis is a plus. Strong knowledge of process chemistry, route selection, optimization, scale-up and crystallization process. Experience with parallel synthesis, OFAT, DOE and QbD for process optimization
- Desirable to have drug development experience, including drug candidate discovery, clinical trials, and regulatory requirements for INDs, IMPDs, and NDAs.
- Experience in writing CMC documents for US and Ex-US regulatory submissions and preparation of technical reports in support of planned regulatory submissions
- Strong analytical skills and problem-solving skills with a track record of identifying and implementing novel solutions.
- Requires the ability to work in a cross-functional team environment
- Strong verbal and written communication
- Flexibility to accommodate multiple time zones as needed
At Marinus, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
Search Firm Representatives Please Read Carefully
Marinus Pharmaceuticals does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
Please see job description
PI181820626
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Marinus Pharmaceutical
July 05, 2022