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Material Planning / Manufacturing Support Specialist
20271 Goldenrod Ln 2nd Floor, Lab 2085 Germantown, MD 20874 US
Job Description
Reporting to: GMP Operations Manager
The Material Planning / Manufacturing Support Specialist leads material handling and supports manufacturing activities as needed for clinical-stage operations. This role owns receiving, inventory control, kitting, staging, and issuance while helping ensure manufacturing suites and support areas are prepared, supplied, and maintained to enable safe, efficient execution of development and clinical manufacturing. The position operates in a regulated environment and works closely with Manufacturing, Quality, Facilities/EHS, and Labs to maintain traceability, documentation accuracy, and schedule adherence.
Key Responsibilities
· Perform receiving, inspection coordination, labeling, storage, picking, staging, and issuance of raw materials, consumables, components, and intermediates supporting clinical manufacturing and development work.
· Maintain inventory integrity, including lot control, expiry management, status segregation (quarantine/released/rejected), cycle counts, reconciliations, and documentation of discrepancies.
· Handle cold chain materials across all temperature ranges (ambient to LN?), including routine monitoring and supporting excursion documentation and response.
· Manage with inbound and outbound logistics, including courier coordination, packing, chain-of-custody documentation, and compliant handling of hazardous materials where applicable.
· Oversee distribution of clinical materials to GMP storage facilities and clinical sites following approved procedures.
· Use and maintain inventory systems (ERP/WMS/LIMS) to ensure accurate transactions, labeling, and recordkeeping.
· Maintain staging areas, point-of-use supplies, and organized storage aligned with 5S and visual management principles.
· Execute kitting and batch staging activities in support of the production schedule; ensure kit accuracy, traceability, and on-time delivery to manufacturing.
· Support cleaning coordination and consumables replenishment (e.g., wipes, disinfectants, PPE, tubing/filters, single-use components) in alignment with site procedures.
· Help maintain inspection readiness by ensuring documentation and suite support processes are current and compliant.
· Follow SOPs and work instructions for material handling, kitting, staging, and manufacturing support workflows; provide input for continuous improvement.
· Partner with Quality and Manufacturing to document deviations, excursions, and material-related issues as needed.
· Work with Facilities/EHS to ensure safe storage, proper material handling practices, and compliant waste management.
Qualifications
· 4 years of experience in materials, warehouse, or manufacturing support operations, preferably in a regulated environment (biopharma, medical device, diagnostics, or similar).
· Working knowledge of GMP/GDP concepts, documentation practices, and material traceability expectations.
· Experience supporting manufacturing operations such as kitting, staging, controlled material movement, and production support in clean or controlled areas.
· Familiarity with cold chain handling and temperature monitoring processes.
· Experience with inventory systems (ERP/WMS/LIMS) and Microsoft Office; strong attention to detail and data accuracy.
· Ability to follow procedures closely and work collaboratively in a fast-paced GMP environment.
Nice-to-Haves
· Clinical supply or early-stage manufacturing experience (Tech Ops, PD, MSAT, or pilot plant).
· Hazmat shipping/receiving experience (DOT/IATA) or willingness to obtain certification.
· Experience supporting deviation investigations, audit readiness, or 5S/Lean initiatives in warehouse or production support settings.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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