Current jobs related to Associate Director – Process/facility - Rahway - Merck Sharp & Dohme
-
Associate Director, Regulatory Affairs UK
3 weeks ago
Rahway, United States MSD Malaysia Full timeAssociate Director, Regulatory Affairs UK The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology and infectious disease therapeutic areas.A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. The individual would manage a team of...
-
Associate Director, Regulatory Affairs UK
3 weeks ago
Rahway, United States MSD Malaysia Full timeAssociate Director, Regulatory Affairs UK The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology and infectious disease therapeutic areas.A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. The individual would manage a team of...
-
Lead Operations Specialist
4 weeks ago
Rahway, New Jersey, United States MSD Malaysia Full timeSenior Operations Specialist - Facilities and Project ManagementThe West Point campus is a key manufacturing site for our company, focusing on vaccine production with a workforce exceeding 2000 employees.This facility is dedicated to the production of both bulk and final dosage forms for our vaccine offerings and is expanding to meet future demands.The...
-
Operations Expert
4 weeks ago
Rahway, New Jersey, United States MSD Malaysia Full timeSenior Operations Specialist - Facilities and Project Lead Job DescriptionThe West Point campus is a significant vaccine manufacturing site with a large workforce. This facility is dedicated to producing bulk and final dosage forms for a variety of vaccine products and is expanding to meet future demands.The Project team for the Live Virus Vaccine Filling...
-
Full Time Director
3 days ago
Rahway, New Jersey, United States Sodexo Full timeJob Title: Full Time DirectorWe are seeking an experienced Construction Project Director to join our team at Sodexo. As a key member of our account team, you will be responsible for delivering and growing a large portfolio of projects.Key Responsibilities:Manage an active and concurrent pipeline of projects and revolving strategic projects spanning...
-
Full Time Director
3 days ago
Rahway, New Jersey, United States Sodexo Full timeJob Title: Full Time DirectorWe are seeking an experienced Construction Project Director to join our team at SodexoMAGIC. As a key member of our account team, you will be responsible for delivering and growing a large portfolio of projects.Key Responsibilities:Manage an active and concurrent pipeline of projects and revolving strategic projects spanning...
-
Associate Director, Pension Investments
4 weeks ago
Rahway, United States Merck Full timeReporting to the Assistant Treasurer, Pension Investments, the Associate Director, Pension Investments will assist in the management of over $25 billion in pension and benefits trust investments. Duties are a mixture of recurring and project related tasks and involve presentations to and interaction with senior management. Responsibilities...
-
Health Safety Environment Director
3 days ago
Rahway, New Jersey, United States ESR Healthcare Full timeESR Healthcare is seeking an experienced Health, Safety, and Environmental (HSE) Director to lead our NorAm region. As the HSE Director, you will be responsible for driving safety culture, developing HSE strategy, ensuring training assignments to all team members, and deploying account, country, and client programs. You will provide oversight and regional...
-
Associate Director Oncology Marketing
4 months ago
Rahway, United States Merk Full timeJob Requirements This posting has been created to build a talent pool for potential positions that we anticipate will be required in the near future within our organization. By applying to this Pipeline Advertisement, you will be expressing your interest in being contacted for roles similar to those described in the Pipeline Advertisement.As a strategic...
-
Full Time Director
4 days ago
Rahway, New Jersey, United States Sodexo Full timeJob Title: Full Time DirectorWe are seeking an experienced Construction Project Director to join our team at Sodexo. As a key member of our account team, you will be responsible for delivering and growing a large portfolio of projects.Key Responsibilities:Manage an active and concurrent pipeline of projects and revolving strategic projects spanning...
-
Senior Process Engineer
1 month ago
Rahway, United States DPS Group Global Full timeSummary DPS Group has an exciting opportunity for a BioPharma Senior Process Project Engineer responsible for equipment commissioning and calibration activities and documentation in a GMP environment. The ideal candidate will have the skill set and technical competency to support project plans, schedules, documentation, facilities and vendor resources....
-
Director health safety environment rahway nj
1 month ago
Rahway, United States ESR Healthcare Full timeDirector Health Safety Environment Location: Rahway, NJ Experience Level: Mid-senior Experience Required: 10 Years Education Level: Bachelor’s degree Job Function: Management Industry: Hospitality Compensation: View salary Total Position: 1 Relocation Assistance: No Job Summary Are you looking for a new rewarding role? Do you have experience working in...
-
Senior Process Engineer
2 months ago
Rahway, United States DPS Group Global Full timeSummaryDPS Group has an exciting opportunity for a BioPharma Senior Process Project Engineer responsible for equipment commissioning and calibration activities and documentation in a GMP environment. The ideal candidate will have the skill set and technical competency to support project plans, schedules, documentation, facilities and vendor resources....
-
Process Engineer
4 weeks ago
Rahway, United States The Spear Group Full timeJob DescriptionJob DescriptionSeeking a Pharmaceutical Process Engineer with minimum of 5-15 years experience.Ideal candidates should have a strong understanding of GMPs and experience providing Project Engineering support End to End in highly regulated pharmaceutical facilities. Candidates should have demonstrated experience with manufacturing...
-
Process Engineer
2 weeks ago
Rahway, New Jersey, United States The Spear Group Full timeJob DescriptionJob Summary:The Spear Group, Inc. is seeking a highly experienced Pharmaceutical Process Engineer to join our team. As a key member of our engineering team, you will be responsible for providing technical support and leadership on various projects, ensuring the successful delivery of assets and project realization.Key Responsibilities:Function...
-
Process Engineer
10 hours ago
Rahway, New Jersey, United States The Spear Group Full timeJob OverviewWe are seeking a highly skilled Pharmaceutical Process Engineer to join our team at The Spear Group, Inc.The ideal candidate will have a strong understanding of Good Manufacturing Practices (GMPs) and experience providing Project Engineering support in highly regulated or pharmaceutical facilities.Key ResponsibilitiesApply technical skills and...
-
Director- Health, Safety, Environment
4 weeks ago
Rahway, United States Hunt and Hire Full timeJob Description: At Hunt & Hire Employment Solutions, we are dedicated to promoting diversity and inclusion in the workplace. We believe everyone should have the ability to reach their highest potential, regardless of their gender, race, or ethnicity. We are here to revolutionize the staffing industry and create a more equitable and diverse workplace. We...
-
Director- Health, Safety, Environment
6 days ago
Rahway, United States Hunt and Hire Full timeAt Hunt & Hire Employment Solutions, we are dedicated to promoting diversity and inclusion in the workplace. We believe everyone should have the ability to reach their highest potential, regardless of their gender, race, or ethnicity. We are here to revolutionize the staffing industry and create a more equitable and diverse workplace. We are committed to...
-
Lead Process Engineer in BioPharma
3 weeks ago
Rahway, New Jersey, United States DPS Group Global Full timePosition OverviewDPS Group is seeking a highly skilled Senior Process Project Engineer specializing in the biopharmaceutical sector. This role involves overseeing equipment commissioning, calibration tasks, and maintaining documentation within a GMP (Good Manufacturing Practice) environment. The ideal candidate will possess the technical expertise necessary...
-
Pharmaceutical Process Engineer
2 days ago
Rahway, New Jersey, United States The Spear Group Full timeJob DescriptionWe are seeking a highly skilled Pharmaceutical Process Engineer to join our team at The Spear Group, Inc.The ideal candidate will have a strong understanding of Good Manufacturing Practices (GMPs) and experience providing Project Engineering support End to End in highly regulated pharmaceutical facilities.The successful candidate will have...
Associate Director – Process/facility
3 months ago
Description
The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities include the following:
The process/facility engineer role at the Associate Director level will serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Associate Director will serve as a team member of the MACS Center Basis of Design Phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.
Additional Supported Areas
As required and in addition to support of the MACS facility the Associate Director may need to provide direct support of the other areas such as:
Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
Prep Lab Area: The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.
**Education Minimum Requirement**:
- Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 10 years relevant experience, or a Master’s degree with 9 years of relevant experience, or a PhD degree with 6 years of relevant experience.
**Required Experience and Skills**:
- Experience in GMP clinical supply facility.
- Experience with Equipment start-up and/or qualification.
- Experience providing technical mentorship.
- Experience with small molecule drug substance and/or biologics process development.
- Experience in leading or supporting compliance investigations and change management.
- Familiarity with US and EU GMP and Safety compliance regulations
- Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)
- Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.
- Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
- Experience with quality systems
- Effective interpersonal and communication skills, both verbal and written.
- Excellent organizational skills to multi-task.
- Desire and willingness to learn, contribute and lead.
- Track-record of independent problem-solving.
**Desired Experience and Skills**:
- Experience building high performance teams, from recruiting to onboarding to ongoing talent development.
- Experience with GMP facility design, start-up, commissioning.
- Experience with managing direct reports or matrix teams.
- Experience with Potent Compound processing and containment systems (e.g., isolators).
- Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
- Experience working in an environment with an Automation System (DeltaV, PLC, etc.).
- Experience with coordinating maintenance activities around processing activities to support reliable facility operation.
**NOTICE** **FOR** **INTERNAL** **APPLICANTS**
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