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EyePoint Pharmaceuticals
Watertown, Massachusetts, United States
12 days ago
EyePoint Pharmaceuticals
Watertown, Massachusetts, United States
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Member Company
EyePoint Pharmaceuticals
Watertown, Massachusetts, United States
12 days ago

Description

Director, Analytical Development Scientist

Overview

See Your Future with EyePoint Pharmaceuticals

We are proud to be named a winner of the 2021 Deloitte Technology Fast 500 award, which recognizes the most innovative, fastest-growing companies in North America. We’re challenging the status quo in bio tech with a singular focus on vision-saving medications delivered through best-in-class proprietary pharmaceutical technologies and unique internal manufacturing capabilities to transform ocular drug delivery.

Our unique culture fosters a science-based entrepreneurial environment, with a collaborative, team-focused approach that embraces diversity, equity and inclusion. Our team’s wellbeing is paramount, which is why we offer comprehensive and highly competitive benefits.

For self-motivated leaders that are passionate about bio pharmaceuticals and ready to make a difference in the lives of patients, EyePoint Pharmaceuticals is a place you can be a catalyst for change and accelerate your career. If you share our vision for preventing blindness and have a passion for bio tech and disruptive change to improve patient care, review the requirements of this opportunity and apply today!

Eyepoint pharmaceuticals is seeking a Director of Analytical Development to join our Research and Product Development group in Watertown MA, reporting to the VP, R&D and Scientific Innovation. The individual will work closely with Formulations, Pre-Clinical/Toxicology, Operations, Quality, and Regulatory affairs department to provide strategic support in development of innovative ocular products.

The ideal candidate should have a strong background in analytical method development, dissolution/release testing, stability management, and setting control strategy for drug substance and drug products.  Experience in the management of CRO’s/CDMOs for technical transfer, setting specifications, reference standard troubleshooting, and optimization of analytical methods is required. Additional responsibilities involve contributions to any post marketing investigations and optimization.  The qualified candidate will interact with other departments, participate in cross functional teams, contribute to the product development plans, and author pertinent sections of regulatory submissions.

The candidate must be a strong team player with excellent communication skills working in a complex cross-functional environment. The candidate must be able to work independently and take initiative by providing input on multiple projects. The candidate must be able to think critically, is intellectually curious, and shows resilience to resolve complex analytical method issues. 

This position is based in Watertown, MA and offers flexible work hours.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

  • Lead a group of scientists to develop and qualify analytical methods for small and large molecule extended-release ocular products.
  • Develop innovative Dissolution/Release methods. 
  • Manage stability program.
  • Validate analytical methods.
  • Support development of bioanalytical methods
  • Troubleshoot analytical methods.
  • Identify and implement improvements to existing EyePoint analytical methods.
  • Support QC investigations of out of trend and out of specification results.
  • Support the development of ocular formulations through all phases of product development.
  • Support the development of new drug delivery technologies/platforms for ocular products
  • Build expertise and knowledge around ocular sustained release methods and summarize findings in presentations and technical reports.
  • Generate data for project progression, technical reports, and regulatory filings.
  • Actively collaborate with the analytical CRO/CDMO laboratories regarding technical transfer of methods and method validation.
  • Scientifically interpret complex data sets and provide sound recommendations for successful product and formulation development.
  • Present experimental plans and data to senior management and CMC, manufacturing, and project leadership.
  • Contribute substantively to patent and publication preparation.
  • Provide guidance for other research staff and advise about quality, timeliness and accuracy of work done.


Requirements

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

  • Proven track record in developing and validating analytical methods with control strategies in support of Pre-clinical through Phase 3 clinical development programs for small and large molecules.
  • Experience in leading and developing a team of analytical scientists to maintain quality of work and timelines.
  • Hands-on experience with analytical and physicochemical techniques, such as DSC, TGA, XRPD, HPLC, Dissolution, KF, Water Activity, FTIR, NMR, RAMAN, and standard biophysical/biochemical techniques.
  • Hands-on experience with Biologics test methods such as ELISA, IEX-HPLC, SE-HPLC, CE-SDS, HC-DNA, FRET and SDS-PAGE
  • Understanding of fundamental biopharmaceutical principles for the development of injectable drug products.
  • Solid knowledge of regulatory requirements for phase appropriate analytical method development. Experience with IND, IMPD, NDA, BLA filing is desirable.
  • Intermediate applied statistical analysis skills.
  • Strong technical writing skills
  • Excellent verbal and written communication skills
  • Ability to multitask and work on a few projects concurrently
  • Detail-oriented

Preferred Qualifications

  • Thorough understanding of polymer chemistry and drug-polymer interaction as they relate to analytical method development.
  • Ability to lead and participate in technical team discussions effectively and collaboratively.
  • Direct experience working with CRO’s/CMOs.
  • Experience with a range of sterile solid/injectable dosage forms
  • Proven ability to apply scientific principles to method development using a rational approach.
  • GLP, GMP, and GxP experience is a plus.

Level of Education Required:

  • PhD in Analytical Chemistry with 10+ years of experience.
  • MS in Analytical Chemistry with track record of successful career progression over a 12-year period
  • BS in Analytical Chemistry with track record of successful career progression over a 15-year period

Number of Years of Experience in the Function and in the Industry:

10 to 15 years of pharmaceutical/biopharmaceutical experience dependent on level of mastery in analytical development.

We are an ophthalmology focused company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders.

EyePoint Company Values include: 

  • Success begins with our People – our employees are valued, relied upon and key to our company’s success
  • Patient First – above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patients
  • Integrity– we are always honest, open, ethical and fair
  • Results-Driven– we are decisive and act with a sense of urgency against clear and aggressive goals
  • Innovation – we strive for continuous improvement through thoughtful risk-taking
  • Team Focus– we work and communicate in a collaborative, respectful and inclusive fashion
  • Diversity & Inclusion - We commit to diversity in our staff and embrace inclusion and acceptance of others without bias

EyePoint Pharmaceuticals is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Information

  • Job ID: 62526195
  • Location:
    Watertown, Massachusetts, United States
  • Position Title: Director, Analytical Development Scientist
  • Company Name For Job: EyePoint Pharmaceuticals
  • Job Function: Analyst,
    Drug Development,
    Scientist
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Ph.D.
  • Min Experience: Over 10 Years
  • Required Travel: 0-10%

See Your Future with EyePoint Pharmaceuticals We are proud to be named a winner of the 2021 Deloitte Technology Fast 500 award, which recognizes the most innovative, fastest-growing companies in North America. We’re challenging the status quo in bio tech with a singular focus on vision-saving medications delivered through best-in-class proprietary pharmaceutical technologies and unique internal manufacturing capabilities to transform ocular drug delivery. Our unique culture fosters a science-based entrepreneurial envi...

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