Head of Manufacturing Science and Technology-MSAT

Bora Pharmaceuticals•Maple Grove, MN

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. This role serves as the primary technical bridge between clients and Bora Pharmaceuticals Inc. (CDMO manufacturing), to ensure processes are robust, compliant, and scalable. This role is largely a client facing role, with responsibility for transfer in and development for all new products coming into Bora Pharmaceuticals Inc. Full drug development including pre-formulation/formulation development and method development. Provide analytical method transfers and validation. Lead all aspects of technical transfers including development and GMP manufacturing, packaging, cleaning and process validation, and oversight of development quality assurance.

Requirements

Bachelor’s degree in scientific area, i.e., chemical engineer, biotechnology, biochemistry, or a related field.
10 years of pharmaceutical manufacturing in technical function or elsewhere within the industry.
High level of experience in product lifecycle management, technical transfer, and product development within a pharmaceutical contract manufacturing organization.
Specialist technical competence and unit dose knowledge in oral solid dose, liquid and semi solid dose forms.
Operational management skills and experience.
Proven capability to lead teams (both line and matrix) to deliver business solutions and benefits.
Proven ability to communicate and influence effectively at all levels within the organization.
Ability to use and interpret data to drive decision-making at both tactical and strategic levels.

Nice To Haves

Masters or other postgraduate degrees in Chemistry, Engineering or Pharmaceutical Science type discipline a plus.
Experience working directly with clients and managing complex projects in a fast-paced CDMO environment is highly preferred.

Responsibilities

Work with Business Development to secure new business across the network; identify fit for plant to manufacture and package; critically review RFPs, and participate in financial reviews on costs.
Maintain full accountability for agreed revenue targets for new business and management of the MSAT P&L, promote growth opportunities for the site and adhere to OpEx budget.
Establish effective collaborative partnerships with the business development team to support and assist in securing new customers.
Build, mentor, and manage a high-performing future-ready MSAT team including driving professional development opportunities and operational excellence.
Ensure that all technical aspects for products in commercial are managed well through the validation lifecycle.
Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and benchmarking best practices.
Maintain compliance with all relevant EHS and cGMP regulations with the department.
Contribute to site leadership team by engaging and influencing strategic decisions for the site.
Provide oversight and management of pilot plant area as a new business unit for manufacturing and packaging.
Own the strategy and execution of process validation (PPQ) and continued process verification (CPV) for new and existing products at the site.
Ensure risk‑based validation approaches using tools such as FMEA, risk assessments, and control strategy development.
Lead the site strategy for analytical method qualification, validation, transfer, and lifecycle management for in‑process, release, and stability methods.
Accountable for all Technical aspects for commercial business, including manufacturing, packaging and customer or new product changes.
Ensure new products are introduced under strict cGMP requirements, and changes to existing products are also managed under cGMP.