External Manufacturing Technical Project Lead
1 week ago
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people's hands by making self-care as simple as it should be. For half a billion consumers worldwide - and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world's most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
About the job:
The External Manufacturing Technical Project Manager provides manufacturing support services to Contract Manufacturing Organizations (CMO) related projects and manages assigned new products from concept to launch. The candidate will serve as the Subject Matter Expert for new products and production related initiatives at CMO's. As a primary technical contact, support the interface of CMO with Opella operational personnel in an effective and proactive way; always working in a positive, efficient, and effective way to address business objectives.
Main Responsibilities:
- Manage CMO produced new products, package/formula changes, and technical transfers of existing products and processes from concept to launch
- Participate in cross functional teams in the selection of new CMOs or the use of an existing CMO for a new project. Coordinate with team members representing Quality Assurance, Product Development, Procurement, and Operations to evaluate and recommend CMOs
- Develop validation strategies for CMO produced products, and review and approve validation protocols and summary reports.
- Provide ongoing technical support for currently marketed products produced at CMO's.
- Perform expert review of all change control documentation for CMO produced products and be able to assess impact of proposed changes on the product's validated state.
- Coordinate with activities of Marketing, Product Development, and Operations Department with CMOs in the development of product, product transfers and packaging for new and existing CMO manufactured products.
- Manage projects, recurring project meetings; issuing meeting notes and action items for all projects managed.
- Prepare and issue project Gantt charts; work with cross-functional project team members to maintain project schedule (identifying any shortfalls or issues in a pro-active fashion).
- Review and approve Annual Product Reviews for all externally manufactured products.
- Other duties as assigned.
- BA or BS in Science or Engineering or a related field.
- Two to Five (2-5) years technical support experience in an FDA regulated environment- preferably within a Consumer Healthcare Company.
- Strong technical acumen in various dosage form delivery systems (oral solids, liquids, emulsion systems, aerosols, powders, etc.)
- Strong working knowledge of various packaging systems (bottles, tubes, aerosols, thermoforming, etc.).
- Excellent written and verbal communication skills with great attention to detail.
- Experience with Microsoft Office Suite, to include: Excel, Word, Outlook, and PowerPoint.
- Team focus with a proven track record of cross functional team leadership.
- Good negotiation skills with proven record of success.
- Relationship building skills as external liaison to the C(D)MO
- Customer service mindset in working with commercial operations and other internal/external functions.
Terms of Employment
Travel as needed to address the organization's needs for External Manufacturing. - up to 10%
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
Opella and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
96,188.00 - 120,313.00 USD Annual
All compensation will be determined commensurate with demonstrated experience. Employees may be
eligible to participate in Company employee benefit programs. Additional benefits information can be
found through the LINK.
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