Method Validation Documentation Specialist

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Located in Monmouth Junction, New Jersey, Tris Pharma has an immediate opening for a Method Validation Documentation Specialist.

Position Summary

The Method Validation (MV) Documentation Specialist supports the MV department by creating, revising and organizing all new and revised specifications and associated test methods and documents in compliance with Management of Change (MOC) system according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) procedures.

The incumbent is also responsible for preparation, revising and maintenance of other departmental documentation including, but not limited to: annual reports, SOPs, raw material qualification reports, risk assessments reports, release and stability specifications, outside contract laboratory reports, etc.

Essential Functions/Responsibilities

• Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
• Creates all new and revised specifications and associated test methods and specifications in compliance with MOC system
• Prepares annual reports for commercial products and supports documents for submission
• Performs compendial review for Research and Development (R&D) projects
• Prepares and assembles raw material qualification reports for commercial products
• Supports documents for submission, residual solvent risk assessment, elemental impurity risk assessment reports, nitrosamine risk assessment reports for drug products
• Organizes and maintains an in-house archiving system for laboratory notebooks, logbooks, data packs, method validation reports and other appropriate scientific documentation; Enters results in release and stability specifications
• Reviews and revises applicable SOPs, as needed
• Performs related duties, as assigned
  
  
  

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum Education And Years Of Relevant Work Experience

Bachelor’s degree in Chemistry or related science field and minimum 8 years’ experience in analytical development or MV in the pharmaceutical or biotechnology industry OR Master’s degree in Chemistry or related science field and minimum 5 years’ experience in analytical development or MV in the pharmaceutical or biotechnology industry.

Special knowledge or skills needed and/or licenses or certificates required

• Hands-on experience with multiple analytical instrumentation which may include: UV/IR, HPLC, LC-MS, GC, GC-MS, ICP-MS, TLC and dissolution apparatus
• Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances
• Excellent recordkeeping ability
• Proficiency with Microsoft Office, including Excel
• Verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
• Planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)
• Ability to identify and distinguish colors
  
  
  

Travel Requirements

0%

Physical Requirements

Laboratory based position

Ability to use personal protective equipment

Anticipated salary range: $80k-100k/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer

Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.