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Executive Director, Biologics Technical Product Leader
2 months ago
Job Description
The Biologics Technical product leader role is responsible for technical leadership and oversight for all biologics molecules end to end. This includes both pipeline and in line products. For pipeline, this includes development and implementation of pipeline commercialization strategy to ensure on-time launch with the best science and most robust processes working closely with DCRC. For inline, this includes development and implementation of technology roadmaps that proactively ensure reliable supply in alignment with the franchise objectives as developed by the value chain team for each product.
This role ensures ownership for the products' technical processes and associated technical challenges.
Primary Responsibilities:
- Managing the portfolio of technical projects associated with the Biologics products. Using standard tools and processes to enable prioritization, resource allocation and ensure project outcome realization.
- Working collaboratively with the GBO OpU and associated VCMT's to align on prioritization and strategies for the delivery of the business needs, in particular for the in line products. Ensuring that the team works with urgency to support the E2E supply chain when issues arise to ensure minimal risk to supply or compliance.
- Developing tools and processes to ensure we are holistically looking at our products and their performance, using data to inform us of stability concerns or potential risks to our compliance posture or continuity of supply
- Provide deep technical oversight of projects within the technical portfolio of products in partnership with the broader LMS&T organization. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by teams supporting in line and pipeline products. Expectation is that this leader will provide a structured approach to technical leadership that enables clear prioritization of the work aligned with the business needs, working with key stakeholders and decision makers.
- Coaching and developing the technical leaders so they are able to support organization and all the complexity that exists today. Ensuring team are continuing to develop their knowledge and skills, It is required that this leader will create an environment through expectations, culture and processes which nurtures and demands both technical excellence and executional excellence. Ensuring reliable launch and sustained supply are achieved and there is both technical knowledge continuity and technical project continuity as the product passes from pipeline to inline.
- Required to comply with our company's 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 in GSEC and within the teams that they interact with.
- May be required to perform other duties as assigned.
Education Minimum Requirement:
- B.S. /M.S. /Ph.D. in one of the relevant Engineering or Science fields
Required Experience and Skills:
- Minimum of 10-15 years experience in biopharmaceutical manufacturing and/or development, preferably a majority spent in science and technical role.
- Demonstrated technical excellence an in depth understanding of biologics molecules, manufacturing processes and commercialization principles
- Experience of biologics development and new product introduction.
- Strong cross divisional networking skills and capabilities
- Experience in Technical product stewardship an advantage
- Demonstrated functional and enterprise leadership, ability to influence at all levels of the organisation.
- Strong collaborative and talent-building skills and the ability to work strategically and in a detail-oriented framework with all levels of management.
- Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment
Core Competences:
Technical
- Deep knowledge and experience of working in a leadership role in the manufacture and/or development of biologic drug substance and/or drug product is required
- Proven record in technical problem solving in a complex manufacturing environment
- Proven record in project/portfolio management
- Experience in on time delivery of E2E Pipeline programs
- Knowledge and experience in ADC's an advantage
Business
- Manage a budget for the team of approximately 20/30 people
- Maintain a focus on COGs and work with the OpU's to continuously see where improvements can be made year on year
- Ensure alignment of the teams portfolio of projects with the business strategy and associated priorities
Leadership
- Focus on Customers and Patients
- Strong communications and collaboration skills
- Act with Candor and Courage
- Make Rapid, Disciplined Decisions
- Drive Results
- Build Talent
- Demonstrate Ethics and Integrity
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.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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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".
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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.
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Job Posting End Date:
06/25/2024*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:06/27/2024
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:R282766
