External Manufacturing Manager
2 weeks ago
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry's top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.Job SummaryThe Manager, External Manufacturing is responsible for all manufacturing activities conducted at our external manufacturing partners. This includes project planning, technical oversight, coordination of development and production activities, tech transfer, continuous improvement, and oversight of cGMP production activities. The manager will have excellent project planning and communication skills both internally and with external partners and be able to travel up to 50% to support manufacturing activities. This role will ensure the highest level of quality and compliance in all activities, review and approve batch records, and resolve investigations. Deep understanding of encapsulation, blister packaging, and labeling are critical to this role.Specific Duties, Activities, and ResponsibilitiesCoordination all external manufacturing activities from pre-clinical support through commercial operations.Ensure effective communication and project management across all functions involved in external manufacturing activities.Lead tech. transfers and scale up manufacturing processes through coordination of technical activities at external manufacturing sitesReview all records and reports ensuring cGMP, quality, and regulatory compliance.Travel as needed up to 50% to ensure manufacturing and development activities are completed with quality and on time. (domestic and some international travel)Provide technical knowledge and oversight of encapsulation, blister packaging, and labeling.Identify, troubleshoot, and resolve technical issues associated with manufacturing operations with input from other technical functions.Identify and implement continuous improvement projects to improve yield, product quality and/or reduce costReview and manage Statement of Works, POs to manage external manufacturing budgets. QualificationsBS degree in a technical field 5+ years of manufacturing management experience in a cGMP environment supporting external operations. Direct experience with encapsulation, blister packaging and/or secondary packaging.Excellent communication including the ability to seek, accept and provide constructive feedback. Ability to align internal and external teams to align on external manufacturing goals ensuring timely support and release of our drug products.Demonstrated background in technical problem solving, tech. transfers and continuous improvement.Mechanical aptitude with solid understanding of general equipment operation including encapsulation and blister packaging.Benefits: Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position. Recruiting Agencies, Please Note: Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
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