External Manufacturing Technical Project Lead

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 .#
** About the job:**#
*
* 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.#
*
* About You:

*** 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.
** Preferred Qualifications
*** 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%
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…