What are the responsibilities and job description for the Product and Process Development Consultants position at Pharmatech Associates?
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.
Primary Responsibilities:
- Responsible for supporting annual sales growth and market penetration of Pharmatech’s PPD services within the global regulated life sciences markets.
- This individual will be responsible for identifying, refining, developing, differentiating and packaging Pharmatech’s key service offerings. These service offerings are to be used to develop the Products and Process Development group and may apply specifically to the following: veterinary and human drugs, combination products, small molecule, biopharmaceuticals, biosimilars, dietary supplements and nutraceuticals, OTC human drugs, in vitro diagnostics and medical device markets.
- The incumbent will have responsibility for client and project relationships
- Within a short lead time and as required, assume leadership responsibilities anywhere across a client’s organization, from Project Relationship Manager to Project Leader to Project Subject Matter Expert.
- Support growth of Pharmatech’s brand as a thought leader in the field of product and process development and as such publish articles and white papers on current global product development requirements, solutions and considerations. Participate in webinars and present at conferences periodically to reinforce Pharmatech brand, expertise and value.
- Mentor Pharmatech staff as part of projects Job Functions:
- Acts a subject matter expert in small molecule product development support marketing, sales, resource planning, and thought leadership including publications conferences and webinars
- This position may be called upon to provide leadership and project management support outside the area of products and process development within Pharmatech’s model for project management.
- Support hiring professionals with the capabilities of executing and supporting the strategic vision and tactical plan for the Products and Process Development
- Provide leadership, management and mentorship, including employees, ICs and outside service providers as necessary
Qualifications:
• Bachelor or master’s degree with a scientific or engineering related major is required • Minimum of 15 years’ experience required. Experience within a manufacturing environment for FDA regulated products
- At least 5 years of formal and direct client management in a consulting role and bring a strong national and/or international reputation and network to support Pharmatech’s PPD groups continued growth
- Experience as a subject matter expert in one or more core elements of the drug development lifecycle
- Must be 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 and understanding 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
- Possess a 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 with the ability to work in a team environment and capable of communicating effectively at all levels of management from the executive level (Board of Directors and C-Level) through the operator and analyst level.
- Capable to travel and work remotely at client sites throughout the United States and internationally
- Ability to work in fast pace and demanding environment
Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
Salary : $139,000 - $176,000