Method Validation Documentation Specialist
Tris Pharma, Inc., Trenton, NJ, United States
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 U.S. and international patents and market several branded ADHD products in the U.S. We also license our products in the U.S. and ex‑U.S. 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 important 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 assessment 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 record‑keeping ability
Proficiency with Microsoft Office, including Excel
Verbal and written communication 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
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.
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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 important 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 assessment 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 record‑keeping ability
Proficiency with Microsoft Office, including Excel
Verbal and written communication 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
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.
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