Job Details

This range is provided by Trotana, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$220,000.00/yr - $290,000.00/yr

Job Title: Senior Director/VP, Manufacturing/CMC

Reports To: Chief Scientific Officer

Function: Small Molecule Drug Substance Development & Manufacturing

Department: Research and Development

OBJECTIVES:

This role will lead the manufacturing function of preclinical and clinical development programs in Trotana's small molecule therapeutics pipeline. This position will design, develop, and optimize synthetic processes suitable for drug substance manufacturing on a production scale. The position further will proactively manage Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) to manufacture regulatory starting materials and drug substances under current Good Manufacturing Practices (cGMP) for non-clinical and clinical studies. Additionally, the position will be responsible for authoring technical and regulatory documentation as required, including development plans, engineering protocols, risk assessments, technical reports, change controls, and Quality sections for IND/IMPD/NDA/MAA submissions.

ACCOUNTABILITIES:

1. Lead technical and operational aspects of small molecule drug substance development and manufacturing projects within Trotana.
2. Design, develop, and optimize synthetic processes suitable for drug substance manufacturing on a production scale.
3. Proactively manage CROs/CDMOs to manufacture regulatory starting materials and drug substances under cGMP for clinical studies.
4. Author technical and regulatory documentation including development plans, engineering protocols, risk assessments, and IND/IMPD/NDA/MAA Quality sections.
5. Hands-on working experience with all stages of drug development and in-depth knowledge of cGMP requirements and CMC regulatory requirements for small molecule drug candidates.
6. First-hand experience in writing/assisting with CMC documents for regulatory submissions and a good understanding of pharmaceutical development, quality, and regulatory issues.
7. Exercise good judgement in elevating and communicating actual or potential issues to CSO.
8. Communicates and negotiates with international Health Authorities as necessary, directly and indirectly.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

1. PhD in organic chemistry with 10+ years' experience in API process development in the biotech or pharma industry.
2. Demonstrated track record of innovation and problem solving in process chemistry.
3. Project leadership experience from early-stage to late-stage drug substance process development, through registration batches and validation batches.
4. Experience in process characterization and validation campaigns is required.
5. Experience in document preparation for NDA/MAA filing is highly desirable.
6. Demonstrated ability to effectively manage CROs and CDMOs to accomplish process development and drug substance manufacturing goals.
7. Ability to collaborate with teams across different cultures.
8. Excellent communication skills and the ability to work in a goal-oriented and team-oriented setting.
9. High level of motivation and a proven record of accomplishment.

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings or client sites, including overnight trips.

Further Information:

Salary range: $220k-$290k

Trotana is a biotechnology company based in San Diego. In addition to a competitive compensation package with stock options, the company offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life insurance, disability insurance and a 401(k) plan. The company is an Equal Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to ...@trotana.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed.

Seniority level

Executive

Employment type

Full-time

Job function

Management and Manufacturing

Industries

Biotechnology