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- Parsippany, NJ
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Our client - a growing Pharmaceutical company in Northern NJ - is looking for a Sr. Regulatory Affairs Associate. The Sr. Regulatory Affairs Associate will helps to put together and submit regulatory submissions to the FDA. These submissions will include: ANDAs, Amendments, Supplements, Annual Reports etc. (There may be additional work involving 505 (b)(2) submissions as well.) This position will also involve effective interaction with other departments with regards to the information required


Our client, a growing Cosmetics Manufacturer located in Central NJ area, is looking for a Project Coordinator. The Project Coordinator will:work with multiple people and departments both inside and outside of the company and will be responsible for implementing projects and managing timelineswill both lead and participate in conference calls/meeting in order to support projectswill create and manage multiple spreadsheets in order to track and report status of the projectswill understand all....


The Commercial Project Manager will oversee and support all project management activities for commercial operations. The primary responsibility will be to support all functions of commercial operations in managing timeline/milestones for pre-launch and launch activities. The Commercial Project Manager will:Work cross functionally with teams in order to update the schedules, manage pre-watch programs etc.Work directly with Commercial Operations senior management in order to help assist in....


We are looking for a Formulation Scientist with experience formulating Parenteral Dosage Forms. The Formulation Scientist will work at our client - a Pharmaceutical Company located in Raritan NJ. The qualified candidate will have experience with Pre-Formulation, Formulation, Scale-up of Parenteral Dosage Forms. Experience with Lyophilized products will be a plus. The Formulation Scientist will be involved in Literature Searches, writing Experimental protocols, identifying CPP's & QTPP's....

- San Diego, CA

Our client - a major Pharmaceutical company in SoCal - is looking for Analytical Chemists. These Chemists will work within the company's Analytical R&D department. Responsibilities will include:Method Development / Method ValidationDevelopment of stability studies Performing literature searches Documenting/Recording all experimental activities in laboratory notebooksThe Qualified Candidate will have analytical methods development experience in a pharmaceutical environment. (4-10+....


Our client - a Pharma company in Central NJ - is looking for someone with strong experience with scale-up/tech transfer of sterile dosage forms (ideally Parenterals). In addition to having strong technical skills - the Qualified Candidate will have good “soft skills” since they will also be interfacing with CMOs. The Company said that they can fill this position at either a Manager or Sr. Manager level. This position requires BS in Chemical Engineering, Physical or Analytical Science or....


Our client - a growing Pharmaceutical company in Raritan, NJ is looking for a Sr. Scientist. The ideal candidate will have experience developing novel LC-MS Methods. They will also have experience developing quantitative analysis methods using mass spectrometric techniques. The qualified candidate will have strong knowledge of high resolution LC-MS (especially structural characterization/elucidation work of small molecules) as well as experience in troubleshooting MS methods. Any experience....


Our client - a growing Pharmaceutical company in Raritan, NJ - is looking for a Group Leader - Analytical R&D. This group will provide Analytical Support to both the Drug Substance and Drug Products areas. The Group Leader will have extensive experience in HPLC, LC/MS, GC etc. and will oversee a group of 2-4 chemists. The Group Leader will be responsible for overseeing the improvement of R&D efficiency ideally by shortening the method development timeline and ensuring the delivery of....


Our client - a growing Pharmaceutical company located in Northern NJ is looking for a Project Manager. The Project Manager will work primarily to support Medical Affairs in a traditional Project Management role. The responsibilities for this role will range from leading task force initiatives to traditional Project support of a Pharmaceutical compound currently in development (Phase I-III). Additional activities will include: leading sub-teams, standard Project Office administrative tasks,....


Our client - a growing Pharmaceutical company in Philadelphia is looking for Formulation Scientists. These are newly created positions. The Qualified candidate will have 3-12+ Years of Pharmaceutical experience primarily in the formulation of Solid Dosage Forms (IR/MR/ER). Experience with additional Dosage Forms is a strong plus. Additional responsibilities will include Report Writing (e.g. Product Development Reports, Submission Batch Reports etc.)

- Bedminster, NJ

A growing Pharmaceutical company in the Bedminster, NJ area, is looking for an Associate Director QA - CMC. This person will be responsible for ensuring CMC QA document review and approvals are performed in a manner that supports clinical release, regulatory approval, and commercialization of the company’s drug product programs. This person will be responsible for support of the following functional areas: Analytical Manufacturing Microbiology This person will also have responsibility for....


Our client, a major Pharmaceutical Company in the Central NJ area, is looking for a Sr. Mgr./Associate Director - Regulatory Affairs. The Sr. Mgr./Associate Director Regulatory Affairs will oversee a variety of projects (IND/NDA/BLA), and they will manage these projects through all phases of development as well as be involved with both post-approval and life-cycle management issues. The Sr. Mgr./Associate Director Regulatory Affairs will:Develop regulatory strategiesProvide regulatory....


Our client, a growing Pharmaceutical Company located in the Metro NY area, is looking for a QA Manager. The QA Manager will be responsible for:QA oversight of components, in-process and finished products etc.Hiring and training of all QA Inspectors & QA Reviewers.Overseeing work performance of all QA Inspectors & QA Reviewers.Ensuring cGMP and FDA complianceMonitoring and supporting quality systems such as laboratory investigations, deviation management, CAPAs, instrument....


Our client, a Pharmaceutical Company in Branchburg, NJ that is experiencing rapid growth, is looking for a Manager - Clinical Operations. The Manager will oversee clinical studies for compounds in variety of therapeutic areas. This position will be involved in developing study plans as well as helping to craft study budgets. Additional responsibilities will include CRO site selection as well as overseeing the CRO site qualification. The Manager will ensure that the clinical studies adhere to....


Our client, a Major Global Pharmaceutical Company, is actively expanding their operations in the U.S. They are currently looking for a Manager/Sr. Manager, Regulatory Affairs. The Manager/Sr. Manager will be responsible for submissions (IND/NDA/BLA) from Cradle to Grave - as well as the development and execution of global regulatory strategies. The ideal Candidate will also have some direct experience communicating with the FDA and various other Global Health Authorities. Additionally the....


Our client - a growing Pharmaceutical company in Raritan, NJ is looking for a Manager - Regulatory Operations. The Manager - Regulatory Operations will be responsible for development and implementation of procedures and systems to support Regulatory Submissions and Regulatory Publishing. The Manager will also be responsible for the establishment and maintenance of an archiving/document management systems and tools (e.g. eDMS, Regulatory Information System, CTD templates, etc.). The Manager....


Our client, a major Pharmaceutical Company in the Central NJ area, is looking for a Mgr./Sr. Mgr. - Regulatory Affairs. The Mgr./Sr. Mgr. - Regulatory Affairs will oversee a variety of projects, and they will manage these projects through all phases of development as well as be involved with both post-approval and life-cycle management issues. The Mgr./Sr. Mgr. - Regulatory Affairs will:Develop regulatory strategiesProvide regulatory guidanceReview documents for submission to FDAOversee the....

- St. Louis, MO

Our client - a major Pharmaceutical company in St. Louis - is looking for a Manager of Validation. The Manager will have overall responsibility for Validation in the following areas: Equipment Cleaning Packaging Process The Manager will be responsible for:Developing and implementing SOPs, Master Plans, Protocols for all of the above listed areas.Ensuring that all Plans and Protocols are compliant with both Company as well as External (i.e. FDA) requirements.Participating in Investigations and....


Our Client is looking for a Director - Technical Operations. This position is an outstanding opportunity to join a rapidly growing Pharmaceutical Company. This role will have a high level of visibility and will interact with both internal groups within the Company as well as external vendors. The Director will be responsible for:Overseeing multiple projects involving the Tech Transfer and Scale-up of Injectable Dosage FormsCollaborating with internal resources and vendors for all technical....

- Coram, NY

Our client, a rapidly expanding Pharmaceutical company located on Long Island, is looking for a QA Associate. The QA Associate will be responsible for a wide variety of responsibilities to include:Will be involved with document review, approval of protocols, approval of reports, lab investigations, batch record review, batch record release etc.Will work closely with & provide Quality support to R&D personnelWill assist in developing Quality SystemsWill assist in writing SOPs for....

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