General Manager, Oral Solid Operations

7/22/20

Langhorne, PA 19047

1013

BS Engineering

FullTimeRegular

General Manager

The General Manager of OSD Operations will fulfill a critical role in ensuring successful manufacturing readiness, site licensure, and ultimately cGMP supply through strong leadership. This position requires tactical and strategic leadership to influence, establish, and implement short and long-range goals, plans and policies related to OSD operations. The position will have executive leadership and plant management production responsibilities and will collaborate with an engineering team to commission and license a new production plant. Upon FDA licensure the position will be responsible for assuring the successful development, transfer, and qualification of manufacturing processes for the company’s commercial oral solid dosage product pipeline. Interacting closely with Product Development, Quality, Regulatory, and other appropriate groups, the candidate will be responsible for development/transfer of manufacturing processes (e.g. drug substance, drug product, finish packaging, ANDA/NDA, etc.), technical management of existing processes, and continuous cGMP compliant supply of commercial products. The Vice President/GM will also manage the company’s external manufacturing contract suppliers (e.g. raw materials, packaging components, labeling, etc.) as related to supply of commercial products.

Key Duties & Responsibilities:

Production

  • Develops, recruits, and maintains a manufacturing staff that will enable the continuous and compliant supply of manufactured products
  • Provides leadership to the team that will develop and implement high quality, robust, and scalable manufacturing processes that meet the needs of the company’s product pipeline
  • Codevelops and maintains manufacturing quality standards that exceed industry expectations
  • Manages contract suppliers, supply agreements, compliance to standards, resources, and budgets
  • Directly supports regulatory ANDA/NDA submissions with data, reports, and filing content
  • Motivates, inspires, and leads a high-performance technical team providing coaching/mentoring as necessary
  • Develops and leads training activities to ensure staff are appropriately qualified, developed, and retained
  • Directs the efforts of personnel responsible for the day-to-day production/product delivery requirements

Compliance

  • Establishes and maintains robust manufacturing procedures that exceed industry/CFR/FDA expectations
  • Promotes and enforces a culture of compliance and quality excellence
  • Works closely with Regulatory to ensure successful NDA/ANDA submissions and regulatory responses
  • Leads/collaborates on critical quality technical reports required for product development, validation, stability,
  • comparability, and manufacturing investigations
  • Establishes and maintains highly credible relationships with regulatory, state, and local agencies
  • Prepares and readies manufacturing team for PAI, biennial, and new product FDA site inspections
  • Refines and further develops the operational related policies and procedures to continually increase quality, compliance, and cost effectiveness

Safety

  • Builds and maintains a culture of individual and product safety that exceeds industry standards
  • Develops operational safety practices, procedures, and policies that eliminate and/or minimize exposure to personnel/staff injury
  • Develops and integrates investigational standard documentation practices upon incident identification
  • Develops and maintains steadfast compliance in response to potential product complaints per FDA/regulatory standards

Strategy

  • Leads the specification, identification, recruitment, training, and daily production leadership of a comprehensive technical team of manufacturing supervisors, technicians & operators
  • Cross functionally collaborates with Engineering, Quality, Regulatory, Development, and Marketing to commissioning (PAI), licensing, and staffing a new manufacturing plant.
  • Develops comprehensive production expansion strategies to further business objectives, generate competitive advantage, support long-range goals, and optimize capital deployment
  • Collaborates with production planning to align production with market demand
  • Develops an adaptable organization that readily accommodates current technologies yielding the highest quality and compliance standards when producing commercial finished goods
  • Defines, establishes, and drives high standards of training, teamwork, morale, and work performance
  • Coordinates with senior management to develop delivery budgets (e.g. contract services, materials, training, capital expenditures) and track/report on this budget throughout the year
  • Maintains sound effective relationships with executive, regulatory (agency), and site leaders

Education/Technical Competencies/ Certifications/ Licenses:

  • A minimum of 20+ years of supervisory and/or manufacturing management experience in pharmaceutical operations with 10+ years in OSD manufacturing and 10+ years in technical leadership roles in an pharmaceutical industry environment.
  • Industry experience as a technical professional supporting the development, launch, and/or production of commercial products
  • Direct experience with regulatory requirements for drug product and drug product manufacturing including NDA/ANDA submissions, correspondence, process validation, post approval inspections, and technology transfer.
  • In-depth knowledge of cGMP and process requirements in early, late- stage, and commercial manufacturing
  • Successful track record of collaborating with Quality, Development, and supplier/contract organizations
  • Strong proven leadership and management skills with a commitment to operational excellence
  • Excellent verbal and written communication skills, detail-orientation, and ability to work productively
  • Experience in developing supply chain strategy and meeting company, performance objectives, and regulatory expectations
  • Established interpersonal skills complemented with strong cross functional manufacturing competencies
  • Ability to motivate teams and bring together diverse organizations in achieving common goals
  • Ability to effectively collaborate and be decisive with highly developed ability to listen, acknowledge, and expand on other inputs and priorities
  • Excellent oral and written communications with the ability to balance all business considerations
  • High energy leadership skills that get results in partnership with team members
  • Ability to be creative and innovative in addressing areas and challenges impacting the business
  • Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work: develops innovative approaches and ideas; presents ideas and information in a manner that gets others attention
  • Takes independent actions and calculated risks; looks for and takes advantage of opportunities; consults with subject matter industry experts when appropriate.
  • Quality oriented with strong attention to detail and driven by exceeding standards
  • BS in Engineering or Science related discipline. Additional degree or applicable certifications desirable (e.g. Project Management, Six Sigma)
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