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About the role
- Senior Manager leading technical transfer and lifecycle management of devices in pharmaceutical innovations. Overseeing global teams and collaborating with R&D for product commercialization.
Responsibilities
- Provide technical leadership to global team of Technical Launch Integrators and Technical Owners.
- Enable collaboration with R&D to optimize the design of devices and primary containers for commercial assembly, packaging, and distribution.
- Drive development, implementation, and validation of device assembly and primary packaging processes at commercial scale.
- Support device assembly and packaging sourcing decisions in partnership with VCM, PES, Quality, Planning and Finance and respective internal sites.
- Enable collaboration with Engineering to ensure equipment is accurately designed, tested, installed, and qualified.
- Support technical transfers and manufacturing process capacity scale-up for internal and external manufacturing sites.
- Delegate work assignments effectively, evaluate performance of employees, and plan developmental opportunities to increase efficiency, encourage job satisfaction and personal growth, and enhance professionalism.
Requirements
- Minimum 12 years of relevant work experience within pharmaceutical or medical device industry
- Prior people leadership experience required with an authentic leadership style and ability to successfully drive and influence virtual teams
- Ability to balance multiple priorities and operate with poise and integrity in a sophisticated and constantly evolving environment
- Strong interpersonal communication skills and ability to collaborate with and influence internal sites, external manufacturers, and global partners
- Ability to work independently and make decisions autonomously, with demonstrated problem solving skills and a results oriented approach
- Proven compliance experience with one or more of the following is required: FDA CFR part 3, 4, 210, 211, 820, or ISO 13485 (e.g., Design Control, Change Control, CAPA, and Complaint Handling)
- Proficient in written and spoken English.
- Requires up to 10% domestic and international travel, including ability to work in an international environment across different time zones
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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