Director, Drug Substance Process Engineering - South San Francisco, CA | Biospace
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Director, Drug Substance Process Engineering

Tricida, Inc.

Location:
South San Francisco, CA
Posted Date:
6/6/2017
Position Type:
Full time
Job Code:
PK004
Salary:
Competitive
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company founded in 2013, focused on the discovery and development of first-in-class therapeutics for metabolic, renal and cardiovascular disease. We have recently closed Series C financing of $55M, thus raising $95M to complete our development program. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs.  The Company is backed by world-class venture capital firms.  

SUMMARY:

Tricida seeks a seasoned hands-on leader to join our rapidly expanding team in the role of Director, Drug Substance Process Engineering. Your talents will be directed toward scale-up, late stage process development, manufacturing and commercialization of an existing polymeric drug candidate and will report to Tricida’s head of Drug Substance Manufacturing and Development.

RESPONSIBILITIES INCLUDE:

•   Manage contract manufacturing organizations (CMOs) to produce Drug Substance supply for clinical trials and commercial use.
•   Oversee production activities at CMOs and provide technical support and troubleshooting.
•   Review of batch records, change controls, and other technical documents.
•   Provide chemical engineering guidance to Tricida’s process development and manufacturing of Tricida’s polymer drug.
•   Provide engineering solutions and technical expertise to support GMP scale up efforts that lead to sustained manufacturing consistency, robustness, scalability, improved efficiency, and reduced costs.
•   Participate in late-stage process development and preparation for regulatory submissions.
•   Participate in the design and implement optimization experiments including multistep syntheses, isolation, and purification of polymer drugs.
•   Lead project team meetings with CMOs/CSPs to ensure manufacturing timelines and forecasts are met.
•   Work closely with manufacturing and GMP operations to coordinate project related equipment and activities.  
•   Provide required support to the Quality/Regulatory functions to establish, implement, maintain, and appropriately document product related process development, tech transfer and GMP manufacturing activities.
•   Prepare technical reports in support of planned regulatory submissions and future process development work.
•   Generate and/or review Process Validation documentation, including Product Validation Master Plans, Cleaning Validation Plans, and Process Performance Qualification Protocols.
•   Develop budgets for Process Development & Engineering for approval by executive management.

Requirements

•   Degree (MS or Ph.D.) in chemical engineering or chemistry.
•   10+ years’ pharmaceutical manufacturing experience.
•   Strong technical background in large scale manufacturing, late stage process development and commercialization of APIs.
•   Champion state-of-the-art technology development and implementation to improve manufacturing processes and analytical methodologies.
•   Fundamental understanding of GMPs, quality, and regulatory requirements.
•   Proven ability to manage CMO’s to achieve goals on aggressive timelines.
•   Thorough understanding of broad CMC aspects concerning the development, manufacturing, and analysis of (polymer) therapeutics.
•   Experience with reviewing master batch records, executed batch records, manufacturing deviations and investigations.
•   Experience with polymer chemistry, manufacturing, and handling.
•   Excellent working knowledge of process safety, QbD, PAT, and DOE.
•   Demonstrated ability to write comprehensive reports at the conclusion of the project.
•   Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
•   Strong initiative and desire to work in a fast paced, team-oriented, dynamic environment.
•   Proficiency with Microsoft software (Word / Excel / PowerPoint).
•   Position requires travel up to 10-20% of the time.

Competitive Compensation and Benefits include:  Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options.  15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
Tricida is located in South San Francisco, CA.  

Chemical Engineering, Chemistry, Drug Discovery, Manufacturing, Pharmaceutical, Polymer, Process, Process Development, Process Engineer, Quality, Regulatory, Validation