Process Development Consultants

Apply Location: San Francisco, CA. Remote work available.

About the role

Pharmatech Associates is seeking Product and Process Development consultants to provide consultation services to our pharmaceutical, biologics, and medical device clients. The nature of our projects varies from client to client and can often be supported remotely.

Responsibilities

• Support annual sales growth and market penetration of Pharmatech’s PPD services within the global regulated life sciences markets.
• Identify, refine, develop, differentiate, and package Pharmatech’s key service offerings for the Products and Process Development group, applicable to veterinary and human drugs, combination products, small molecule, biopharmaceuticals, biosimilars, dietary supplements and nutraceuticals, OTC human drugs, in vitro diagnostics, and medical device markets.
• Assume leadership responsibilities across a client’s organization, from Project Relationship Manager to Project Leader to Project Subject Matter Expert, with short lead times as required.
• Support growth of Pharmatech’s brand as a thought leader by publishing articles and white papers on current global product development requirements, solutions, and considerations.
• Participate in webinars and present at conferences to reinforce Pharmatech’s brand, expertise, and value.
• Mentor Pharmatech staff as part of projects.
• Act as a subject matter expert in small molecule product development, supporting marketing, sales, resource planning, and thought leadership, including publications, conferences, and webinars.
• Provide leadership and project management support outside the area of products and process development within Pharmatech’s project management model.
• Support hiring professionals capable of executing and supporting the strategic vision and tactical plan for the Products and Process Development group.
• Provide leadership, management, and mentorship to employees, independent contractors, and outside service providers as necessary.

Qualifications

• Bachelor’s or master’s degree with a scientific or engineering-related major.
• Minimum of 15 years of experience, including experience within a manufacturing environment for FDA-regulated products.
• At least 5 years of formal and direct client management in a consulting role, with a strong national and/or international reputation and network to support Pharmatech’s PPD group’s continued growth.
• Experience as a subject matter expert in one or more core elements of the drug development lifecycle.
• Current and proficient in newly introduced global concepts, practices, and procedures within the regulated life sciences industry.
• Experience in performing a wide range of formulation, process development, and validation of multiple pharmaceutical/biological dosage forms.
• Strong CMC understanding and process design experience for early and late-stage products, with several examples of successful regulatory filings within the US FDA.
• Solid experience with writing and evaluating technical content for regulatory submissions for pharmaceutical small molecule therapies, biologics, cellular therapy, and/or combination products, including INDs, NDAs, BLAs, and MAAs.
• Essential knowledge of QRM, QbD, and QMS frameworks, along with strong practical knowledge of ICH, FDA, and EMA expectations and requirements.
• Experience in manufacturing equipment automation as well as development and validation using GAMP.
• High level of business acumen with demonstrated business and financial management skills.
• Exceptional personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations.
• Outstanding English communication (written and verbal) and dynamic interpersonal skills, capable of communicating effectively at all levels of management from executive (Board of Directors and C-Level) to operator and analyst levels.
• Ability to travel and work remotely at client sites throughout the United States and internationally.
• Ability to work in a fast-paced and demanding environment.