Job Description

External Manufacturing Operations Coordinator, CMC Development, Pharma

CONTEXT & INITIATIVE DESCRIPTION

Our Pharma client is seeking an External Manufacturing Operations Coordinator to support its CMC (Chemistry Manufacturing Controls) Development team with vendor management and oversight for our client’s external manufacturing CMO (Contract Manufacturing Organization) partners. Key responsibilities include supporting building and maintaining close relationships with manufacturing site partners, overseeing manufacturing projects, supporting site qualification activities, monitoring site performance, and driving rapid issue resolution. This is a highly cross-functional role which will require close collaboration with our client’s Technical Operations, Supply Chain, Quality, Regulatory, Project Management, Analytical Development, and Development groups. This individual must be an enthusiastic self-starter who is highly detail-oriented, organized, and results driven.

**Please Note: This role is not expected to be a Technical SME (subject matter expert) - the focus is truly relationship/vendor management and cross-functional collaboration. Each technical group at our client will be responsible for the technical oversight and technical delivery of work with vendor partners.

This role will report into the Associate Director of CMC Development and Quality Control.

DUTIES/EXPECTATIONS:

• Support the conduct of routine meetings with external manufacturing sites in conjunction with internal cross-functional groups. Prepare and distribute agendas and meeting minutes.
• Track manufacturing site performance; promptly communicate and escalate manufacturing issues to internal SMEs (subject matter experts) to ensure rapid resolution.
• As a facilitator and coordinator, support the timely preparation and review of relevant manufacturing documents and quality records associated with cGMP manufacturing operations such as change controls, investigations, specifications, procedures, validation protocols, analytical methods, reports, etc.
• Partner closely with the Project Management group to prepare, maintain, and communicate project timelines and workplans, where appropriate.
• Perform invoice reconciliation and other financial accounting associated with manufacturing projects, as needed.
• Prepare and present updates at regular internal work group and team meetings; support the preparation of presentation materials for client senior leadership, when required.

MUST HAVES – QUALIFICATION SUMMARY

• BS Degree in Chemistry, Analytical Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or equivalent discipline
• Minimum of 5 years of experience in Pharma/Life Sciences, with at least 3 years in CMC (chemistry manufacturing controls)
• Solid understanding of cGMPs as well as pharmaceutical manufacturing and release within a cGMP environment.
• Must be proficient in the Microsoft 365 environment (PowerPoint, Excel, etc.)
• Familiarity with collaborative project management tools such as Microsoft Project, Smartsheet, Monday, Jira, etc.
• Impeccable organization skills
• Excellent interpersonal, verbal, and written communication skills with the ability to work with uncertainty and to resolve conflict in a constructive manner.
• Self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.

NICE-TO-HAVES

1. Familiarity with US, European, Japanese, Chinese, and ICH regulations and industry standards for pharmaceutical manufacturing
2. Experience with management of external contract manufacturing and/or testing vendors

TRAVEL & LOCATION

Hybrid; 3 days per week onsite at client’s facility in University City area, Philadelphia, PA with the other 2 days per week remote

START & TERM

Immediate. 12-month initial contract with possibility for extension or conversion to perm

“Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.”

“W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick 􀆟me if required by law in the worked-in state/locality.”

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