Senior Manager Process Development and Formulation
The Sr. Manager – Formulation & Process Development will oversee pharmaceutical product development activities from laboratory scale up till exhibit/PPQ batch manufacturing for sterile injectable products. As a formulation and process development leader, you will champion the process of site technology transfer for multiple aseptic ANDA products starting with engineering batch manufacturing till process validation/PPQ batches. The incumbent is responsible for leading formulation and technology transfer team.
Essential Duties and Responsibilities:
- Establish R&D process for technology transfer for transferring lab processes to manufacturing site to support ANDA regulatory filings batches.
- Work closely with site functions – operations, quality, engineering, validation, supply chain, procurement, and MS&T to bring new products to the site.
- Establish R&D team capability to scale up products at site, troubleshoot any issues arising during process scale up, and during the manufacturing registration batches to support ANDA regulatory filings.
- Lead New Product Introduction change control process and work with department functional leads for gap assessments.
- Define process to update product development reports to include scale up data from engineering and exhibit/PPQ batches.
- Lead engineering and exhibit batch manufacturing process including batch protocols, sampling, and working with manufacturing and quality team in sample management.
- Lead product transfer gap assessment, in-process control, and FMEA analysis to identify critical/key process parameters.
- Represent organization to establish R&D laboratory at the company’s manufacturing site including hiring R&D chemists.
- Oversight and management of site technology transfer of ANDA aseptic products at the site.
- Translate product development project requirements into a robust, scalable technical design.
- Resolve complex problems by applying sound engineering principles, utilizing experimental, and analytical methods to a range of technical product development challenges over a range of products from simple sterile injectable vial products to more complex pre-filled syringe combination products and oral solid dosage forms.
- Work closely with both functional and project managers to identify and mitigate technical issues, manage project milestones to adhere to project timelines.
- Deliver new drug solutions as a technical leader on a cross-functional project team through all phases of the project lifecycle, from concept through launch.
- Develop and guide technical design/methodologies to achieve success in developing combination products.
- Mentor and motivate team members and junior associates while coaching them through activities such as bench studies, pharmaceutical product development data analysis, FMEAs, combination product development, validation requirements, vendor interactions, material, and component specifications.
Basic Qualifications and Capabilities:
- Bachelor of Science Engineering or a similar technical degree. A post graduate degree is desired but not required.
- Preferred minimum of 12 years related industry experience (it may be a combination with advanced degree education).
- Experience working in FDA and DEA regulated environment.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
- Willingness to travel up to 20% of the time (preferred)