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Senior Manager, Early Stage Combination Product Development
4 months ago
Columbia, MD, USA Req #1260
Friday, May 3, 2024
Kindeva Drug Delivery (Legacy Meridian Medical Technologies) is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
ROLE SUMMARY
As Senior Manager, Combination Product Development – Early Stage, you will work with internal and external partners to identify new opportunities and secure new product development projects for our team. The role requires a high performing induvial who has a demonstrated interest in the combination product industry (particularly injectables) and the end-to-end product development process.
This role is responsible for coordinating proposal preparation for new projects and includes assisting with timeline and budgetary estimation as well as proposal drafting. This person interfaces with current and potential clients, in both the public and private sectors and with internal SMEs to help define the project requirements and details and to acquire information for proposal preparation. The may also coordinate specific development or technology transfer activities as needed.
This is a unique opportunity to have a direct impact on delivering final product solutions to our partners, patients, and have direct impact on the overall success of the organization.
We are building a culture of individuals who embody our PRECISE Values and expect you to lead with personal responsibility, respect, excellence, transparency, innovation, commitment, and energy.
ROLE RESPONSIBILITIES
1. Coordinate proposal preparation based on technical understanding of the product development and design control process
2. Coordinate cross-functional SMEs and Project Managers to provide information for proposal preparation
3. Assist with timeline and cost estimates for activities based on industry experience and feedback from SMEs
4. Manage vendors and sub-contractors as needed.
5. Communicate with clients and internal cross-functional teams to clarify project requirements and assemble data for proposal
6. Coordinate specific technology transfer activities or development activities
7. Support drafting and review of proposals
8. Stay aware trends and opportunities in the injectables combination product development industry.
9. Develop and champion the proposal and early stage development process
10. Support and champion Combination Product Development department initiatives as need.
BASIC QUALIFICATIONS
• PhD Degree, with 7+ years Pharmaceutical/Med Device Development experience
• M.S. Degree in Science or Engineering discipline with 10+ years Pharmaceutical/Med Device Development experience
• B.S. Degree in Science or Engineering discipline with 13+ years Pharmaceutical/Med Device Development experience
• Ability to work on-site in Columbia, MD (2 – 3 days per week)
Preferred Qualifications
• CDMO experience
• Understanding of combination product design, development, and commercialization process
• Conceptual design skills
• Strong mathematical, analytical, and reasoning skills
• Strong problem solving skills
• Strong cross-functional communication skills
• Good customer communication and service skills
• Good organization skills
• Being able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
• Strong written and oral communication
• Project management
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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