Operations Manager - Lexington, United States - Formerly Summit Biosciences Inc. | KDD

Description

Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation + annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

Description:

In this hands-on position, the incumbent is responsible for managing the Manufacturing Operations team during the process of manufacturing products, performing scale-up and validation activities and preparing for commercial launch of nasal spray drug products in an FDA regulated cGMP pharmaceutical manufacturing environment.

The incumbent is also responsible for assisting with or leading manufacturing capacity planning which includes expansion, design and build activities, expansion of offices and laboratory space, procurement of equipment for current and future needs, oversight of plant commissioning and validation activities, hiring and development of staff, troubleshooting and optimization of processes.

Essential Duties:

• Organize, prioritize and execute manufacturing activities, including process and cleaning validation to prepare for commercial cGMP manufacturing.
• Implement, optimize, and troubleshoot manufacturing processes and equipment.
• Develop and execute/coordinate execution of protocols to support manufacturing process development and manufacturing equipment trials.
• Design and implement new manufacturing processes or changes to existing processes and oversee new equipment implementation or modification and validation.
• Write, execute, and review validation protocols for manufacturing/support equipment, processes and cleaning validation.
• Prioritize and guide resources in the design of new or improvements to existing manufacturing processes to deliver FDA compliant production capacity on time and within budget according to business plan.
• Assist with managing capital plans for facility and production equipment related spending to assure production is in a position to meet new product development and product launch manufacturing requirements.
• Provide input to the specification and selection of manufacturing equipment and utilities.
• Lead projects such as new equipment design and procurement, technology transfer, process design and optimization, scale-up activities, process and cleaning validations.
• Work with QA and compliance groups to validate drug product manufacturing processes for regulatory submissions, preparation for PAI and commercial production.
• Provide guidance and oversight of documentation systems for functional areas.
• Writing, review and approval of technical documents and reports such as protocols, batch records, SOPs, filing documentation and other cGMP documents.
• Develop and supervise direct reports.
• Independently champion manufacturing, engineering and validation projects.
• Identify continuous improvement and cost savings opportunities.
• Other duties as assigned.

Qualifications:

• BS in scientific related field, engineering or equivalent experience.
• 7 years of experience in pharmaceutical manufacturing process development, process engineering, optimization and validation related functions.
• Hands on experience in validation, equipment troubleshooting and repair.
• Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs, Process validation, cleaning validation and Computer Related Systems validation.
• Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, and pharmaceutical processing and plant equipment.
• Expert knowledge of principles of technology transfer, process investigations, scale-up, process validation and optimization of liquid fill dosage forms and sterilization.
• Excellent technical writing, communication and organizational skills.
• Experienced in financial and accounting principles/spreadsheets and Project Management.
• Exceptional leadership and interpersonal skills and the ability to work well in a team environment.
• Qualified to work with controlled substances.