Associate Director, External Manufacturing Technical Operations
Company: Institute for Credentialing Excellence
Location: West Point
Posted on: April 8, 2021
Institute for Credentialing Excellence (ICE)
- Associate Director, External Manufacturing Technical Operations
M Associate Director, External Manufacturing Technical Operations
Are you interested in being an Associate Director of External
Manufacturing Technical Operations with our company? Reporting into
a Director, Pharmaceutical Technical Operations - External
Manufacturing Tech Strategy and Execution, you will be responsible
for leading the technical interface with strategic external
partners at the Focus Factory level for the Organon CMO platform.
This role acts as the technical interface between the company and
Organon Contract Manufacturing Organizations (CMOs).
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the
- Be the technical point of contact for the CMO and collaborates
with other core functions (Quality, Operations, Supply Chain) and
also other specialty Centers of Excellence (COE) in the Science &
- Technology transfers, Investigations, Process Improvements,
Project Management and Change Control.
- Technical support and resolution of Quality issues such as
Deviations and Customer Complaints.
- Functioning independently and providing coordination,
communication, and oversight on all technical matters pertaining to
the assigned external partners.
- Responsibility for the technical aspects of Fact Finding around
quality and supply investigations.
- Together with the Focused Factory Team (Ops, Quality, Tech),
establishing a calibrated technical oversight approach based on the
capabilities and technical competence of an external partner.
- Together with the Factory Focused Team, establishing clear
expectations, measures and periodic monitoring of operational and
quality performance associated with the assigned external
- Providing technical expert consultation and review on
- Participating in Technical due diligence assessments.
- Assuring site technical readiness for all new product
introductions or transfers.
What skills you will need:
In order to excel in this role, you will more than likely have:
- B.S. degree in Engineering, Chemistry or Pharmacy.
- At least 8 years of hands on pharmaceutical manufacturing
experience in the areas of process start up and technical transfer
or demonstrated experience in pharmaceutical and packaging
operations in general and solid dosage in particular, including
quality systems and process technology.
- Demonstrated deep technical skills in the areas of solid dosage
- In-depth understanding and proven expertise in application of
quality systems, especially technical subsystems related to process
and equipment qualification, change control, deviation management
and cleaning qualification;
- Advanced understanding of the relevant scientific/ technical
concepts to execute routine and increasingly complex tasks;
advanced working knowledge in the relevant scientific /technical
techniques and is able to apply those techniques to routine and
increasingly complex tasks.
- Technical skills additionally in the areas of liquid,
cream/ointment, and packaging operations.
- Expertise in MPS including Lean Six Sigma green belt level
certification, with black belt preferred.
- Statistical data analysis with Minitab.
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.
For more information about personal rights under Equal Employment
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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. We are an equal opportunity employer, committed to
fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp &
Dohme Corp., Kenilworth, 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.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
- Job ID: 56381796
- Position Title: Associate Director, External Manufacturing
- Company Name: Merck & Co., Inc.
- Job Function: Other
- Job Type: Full-Time Jobs You May Like M Merck & Co., Inc. West
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Monitoring Senior Specialist 2025 M Street, NW, Suite 800
Washington, Dist. Columbia 20036 (202) 367-1165
Keywords: Institute for Credentialing Excellence, Columbus , Associate Director, External Manufacturing Technical Operations, IT / Software / Systems , West Point, Georgia
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