Job Description
The Global External Manufacturing Technology Group is a fast-growing area of the manufacturing network tasked with ensuring reliable safe and compliant manufacturing of drug substance and drug products. Specifically, we manage tech transfer projects from R&D and inline nodes, develop or continuously innovate processes, and we manage supply issues including trouble shooting.
The technical vertical External Manufacturing is the steward of the processes and is responsible for end-to-end project management of R&D and inline projects. Our company has both large and small molecule external networks and this opportunity is covering the Large Molecule drug substance as the primary focus.
Job Functions
Want more jobs like this?
Get Project Management jobs in Rehoboth Beach, DE delivered to your inbox every week.
- As overall leader or technical leader you will be focusing on leveraging external suppliers for LM drug substance process development, scale up, full-scale production and commercial lifecycle management. You will be part of the External Manufacturing Technology Management Group and will be responsible for a portfolio of LM drug substance projects and or supply nodes with a focus on in-line supply. The potential project types include sourcing, technical transfer, R&D, process improvement & innovation, and trouble shooting.
- Spot audits and sourcing support on behalf of other team members will be required at times.
- The role is global and is a perfect fit for individuals with a strong drive for excellence and achieving tangible business results. Critical Skills include strategic thinking and proactive project management with business and technical acumen, verbal communication, and electronic communication. The individual needs to be able to act independently and travel as needed.
- At the Associate Director level, a focus will be placed on the technical leadership during all aspects of drug substance sourcing, process development, commercialization, and subsequent lifecycle management. Once a supplier is selected, the individual will then be fully responsible for end-to-end execution of the project as the leader of execution managing both the internal drug product customers and the external supplier during the technical transfer or process development. Once the technical transfer, validation and regulatory approval for a sourcing project is completed and for assignments to in-line supply, leadership of the company's Supplier Technical Management program will be expected. In addition, each member of the technology team will contribute to generating innovation and systems improvements as appropriate.
- The individual will be expected to partner with External Manufacturing & Global Procurement organization of Manufacturing and the different functional departments to complete global sourcing & development projects. Here the individual will define the requested services including generating technical packages, lead technical due diligence for supplier selection, and verify that the aspects of supplier selection are considered appropriately, including assurance of supply, quality, service, cost and innovation.
- At all times, the individual must be adept at managing customer relationships, internal to the company and external suppliers.
- Supplier Technical Management will be conducted to ensure the on time and full delivery of drug substance for our company. The individual will be expected to manage a defined set of suppliers and act as steward for select drug substances and:
- Lead cross functional meetings with the external suppliers and company's internal personnel to monitor the technical aspects of the relationship including tracking all changes, deviations, and improvement projects.
- Lead the process change team inside of our company's internal or external formulation facilities, regulatory, and quality to execute changes at the supplier.
- Follow up on deviations and ensure they are resolved quickly and appropriately.
- Ensure appropriate knowledge management of drug substance technology.
- Develop and pursue innovation projects with the supplier to improve process efficiency and reduce Cost of Goods (COGs)
- For R&D projects guide process development at the supplier
- Leverage appropriate software systems including for supplier communication and change control.
Importantly, for all assignments the Associate Director must:
- Provide strong leadership and business acumen for project management and lead cross-functional team members effectively.
- Display our company's leadership behaviors and demonstrate a high emotional intelligence.
- Create overall project schedules with Microsoft Project including input from cross-functional partners (regulatory, formulation, supply chain, quality, procurement, R&D) and ensure they are appropriate for the project delivering end to end outcomes.
- Work closely with external suppliers to proactively develop or assess the manufacturing process, evaluate processing equipment, and limit risks during scale up, transfer or process changes.
- Present status updates via Microsoft Power Point in the relevant governance forum meetings
- As required, the individual will assist communications with the suppliers during trouble shooting or visit facilities to conduct due diligence.
Minimum Education Requirement and Experience:
- Bachelor of Science Degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with ten (10) years of experience in development of a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA etc.) and a demonstrated high level of technical capability. OR
- Master of Science Degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with eight (8) years of experience in development of a wide array of LM drug substances (monoclonal antibodies, antigens for vaccines, antibody drug conjugates, m-RNA etc.) and a demonstrated high level of technical capability.
Required Experience or Skills:
- A minimum of 4 years spent in LM process development roles.
- A strong business acumen, communication skills, and a proven track record of managing projects in the areas of sourcing, process development & commercialization, tech transfer, manufacturing process troubleshooting and supply of biotechnology products.
- Strong Leadership attributes including a global mindset.
- Demonstrated ability to lead cross-functional teams with an end-to-end supply chain view.
- Ability to collaborate across functions and geographies and support global activities.
- Strong interpersonal and communication skills
- Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network.
- Ability to use Microsoft Project and the Microsoft suite of applications.
- Travel: 15 to 30%
Preferred Experience and Skills:
- PhD in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable with a minimum 7 yrs. of relevant experience.
- Understanding and experience in process scale up for LM drug substances.
- Expertise in trouble shooting of upstream and downstream operations.
- Demonstrated track record of managing technical project in global CMOs.
- Experience in due diligence audits of CMOs.
- Working knowledge of Regulatory strategy and execution in EU and US (FDA or USDA).
- Six Sigma and/or Project Management Professional (PMP) certification preferred.
#EBRG
NOTICEFORINTERNALAPPLICANTS
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
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
$135,500.00 - $213,400.00
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.
Search Firm Representatives Please Read Carefully
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:
Domestic
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:
08/22/2024
*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:08/22/2024
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:R305160