Job Information
Merck Director, Tech Transfer Group Leader (50/50 Job Share) in Rahway, New Jersey
Job Description
We are seeking a highly motivated individual for the role of Director, Tech Transfer Group Leader in Large Molecule Technology Transfer within Technical Product Leadership. This role will share leadership of a team of scientists and engineers with a focus on end-to-end technical transfer leadership for technology transfers to all large molecules in pipeline and inline space. This role will involve management of individual contributors, as well as people managers.
The incumbent will demonstrate a deep expertise for people management leadership and the product/process sciences and engineering. The incumbent will have broad, experience-based skillsets in Technology Transfer with key focus areas of standard work, right first-time success for commercial scale, partnership with manufacturing science & technology, and in applicable business processes including program/portfolio management tools working with internal and external manufacturing partners and influencing technical strategy. The incumbent will partner with groups across our Company and that include Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain. The end-to-end scope includes Drug Substance and Drug Product for all large molecules. This leader is expected to contribute to ongoing business process improvements and all Tech Transfer (TT) activities.
This role will be a 50/50 job share with an existing Director, Tech Transfer Group Leader, who works remotely.
Key Responsibilities:
TT E2E group leadership (50/50 with another director):
Responsible to manage technology transfer E2E leaders. May act as TT E2E lead.
Coach TT leads for best practices and continuous improvement mindset.
Coach and manage team dynamics, empower, and develop employees to understand all stages of technology transfer/validation and life cycle management.
Coach team to build strong partnership with all the relevant partners and stakeholders.
Drive division wide initiatives that will enable continuous improvement in large molecule commercialization and life cycle management.
Responsible to ensure learnings are shared and put into standards. Ensure TT standards and workflows are applied during each TT.
Serve as coach for identifying and resolving technical risks (know the gaps in capabilities of their TT leads).
Accountable for resource planning for large molecule technology transfer leaders.
Help the team to navigate through TT Technical Issues and escalations.
Required to comply with our Company Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
Work collaboratively to drive a safe and compliant culture.
Leading / Aligning with Partners:
Build strong cross-divisional partnerships with site leaders, functional management, and other stakeholders (Research & Development, Commercialization, Tech Ops, Ops, Quality, Analytical, Regulatory-CMC, and Supply Chain, etc.)
Help resolve conflicts with operation units and sending functions.
On-time Delivery:
Manage and accountable for multiple technology transfer activities with end-to-end visibility for all TTs within the team.
Ensure TT project deliverables (metrics) are met and are on time for each TT.
Review regulatory filing of related sections and regulatory approval of the TT nodes.
Planning / Governance:
Coach TT leads for TT end-to-end meetings, attends stage gates at TT local governance.
Help aligns multiple program and site goals to execute overall TT portfolio.
Education:
- B.S. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of 10 years of relevant experience
Leadership / Business Capabilities:
Has experience managing teams. Track record of motivating, mentoring and coaching teams.
Manages effectively with diverse teams (cross-functionally, cross-culturally, and across internal / external sites) to align and drive TT results.
Viewed as a proven leader.
Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.
Works well in ambiguity.
Able to articulate TT to others.
Establishes clear goals, delegates effectively, holds self and others accountable.
Flexible and adaptable to dynamic situations
Cross-functional team management; successful at indirect management.
Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.
Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.
Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.
Technical Capabilities:
Expertise in technical aspects of product commercialization and life cycle management
Strong scientific knowledge of multiple TT types including vaccines / biologics drug. substance, drug product and analytical.
Proficiency with change control, deviation management and BLA/MAA regulatory license documents.
Demonstrated creative conflict resolution and problem-solving skill.
Strong knowledge of global regulatory guidelines and cGMP principles.
Demonstrated experience with lean operational excellence in manufacturing.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$164,800.00 - $259,400.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/21/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 06/21/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R299056