Reg. Affairs Project Manager  (APPLY NOW)

This position is responsible for managing the regulatory aspects of projects/products, including the preparation and submission of correspondences and applications to regulatory agencies. The functions are as a direct liaison with regulatory authorities and facilitate the review and approval process of applications. This person leads and/or participates in project team meetings, by providing regulatory support to ensure compliance with all FDA requirements and provides product approval strategies with limited oversight from the Regulatory Affairs Program Manager.

BS degree with 7 years experience, MS/PharmD with 4 years experience, or PhD with 2 years experience in pharmaceutical regulatory-related or equivalent experience. Minimum of 3 years work experience in writing ANDA’s. Excellent written, verbal, organizational and interpersonal skills. Scientific writing experience. Detail-oriented and good problem solving skills. Ability to work independently, as well as within a team. Ability to manage and prioritize multiple projects to meet established deadlines.

Scientist (APPLY NOW)

This position will provide scientific advice, review and direction to assigned Analytical Development Department projects by developing analytical methodology to support Product Development functions.  Method development includes literature research, analytical investigations, and validation according to cGMP.  Other duties include cleaning validation support, technology transfer to Quality Control, stability testing, competitive product deformulation, and formulation support.  The person will prepare relevant SOPs, validation, stability and product investigation reports

Lab Analyst (APPLY NOW)

Chemist (APPLY NOW)

Responsible for performing and documenting required testing in the Quality Control laboratory for Finished Products, Raw Materials, Stability, and/or Technical Support groups. The position is responsible to provide information and training for the safe handling of potentially harmful materials.  This may include updating repackaged raw materials MSDSs, reviewing new chemicals and recommended safety measures, hazardous waste management (identification, accumulation and removal), providing technical expertise as an alternate emergency coordinator and departmental safety officer.

QA Quality Systems Manager (APPLY NOW)

Responsible for ensuring the quality of products by managing the quality systems that support operations in regards to 21 CFR, Paddock Policies and SOPs and ensuring that the components supplied and used during operations meet cGMP in regards to 21CFR.

Four-year degree in a technical field, preferably in Chemistry or Microbiology, with 5 years of experience in Quality in the medical device or pharmaceutical industry. Prior experience in management is required.  Prior experience managing a GMP investigation program is required.

Scientist III (APPLY NOW)

Responsible for formulating generic pharmaceutical products in dosage forms that may include solid oral, semisolid topical, and liquid oral.  Duties include analysis of innovator product composition, any associated patents, planning execution of formulation strategies for Paragraph IV ANDA filings, and carrying out formulation development studies resulting in a robust and cost-effective formulation and manufacturing process.

A minimum of a Bachelor's of Science degree in a chemical engineering or scientific discipline with a minimum of 8 years of experience, MS with 5 years experience, or PhD with 2 years experience.  Scientist III level critical requirements: Research, development, and scale-up experience in either, or any combination of modified-release solid dose, topical semisolids and oral liquids a plus.  Proven ability to plan and manage multiple small projects in support of a greater development team.   Working knowledge of regulatory requirements for pharmaceutical industry, most especially cGMPs. Demonstrated technical writing skills in support of regulatory filings.  Significant experience in late-stage development programs, pharmaceutical process commercialization and technology transfer.  Excellent communication skills, both written and oral. Good interpersonal and organizational skills are fundamental to success in this position. The incumbent should demonstrate the ability to exercise independent judgment, yet recognizing the complexity of the work, and work effectively in a team environment.