Contract Method Validation Jobs in Minnesota (NOW HIRING)

About 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.

Job Summary

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.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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 riskbased 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 inprocess, 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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience, Skills

Required:

• Bachelor's degree in scientific area, i.e., chemical engineer, biotechnology, biochemistry, or a related field.

Preferred:

• Masters or other postgraduate degrees in Chemistry, Engineering or Pharmaceutical Science type discipline a plus

Experience

• 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.
• Experience working directly with clients and managing complex projects in a fast-paced CDMO environment is highly preferred.
• 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.

Compensation Range: 192,000 - 250,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives

• Comprehensive health coverage including medical, dental, and vision insurance

• Retirement savings plans with employer matching contributions

• Paid time off

• Professional development opportunities

• Employee wellness programs and resources

• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.