Us PTC Therapeutics

Us PTC Therapeutics

Scientist II, Formulation Development

USA - New Jersey - Bridgewater · Mid · Contract

Sponsorship not specified$133k-$158kDetected 5 days ago
GMPMicroscopyMass SpectrometryAnimal StudiesCommunicationProblem SolvingTime ManagementPublic SpeakingMicrosoft OfficeGxP

About the role

  • PTC Therapeutics is a global commercial biopharmaceutical company.
  • For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
  • We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Responsibilities

  • Designs and develops robust formulations and manufacturing processes for small molecule compounds from drug discovery and/or development programs for preclinical and clinical studies.
  • Prepares experimental designs, evaluates data, coordinates and executes pre-formulation, formulation, and process development studies and identifies pharmaceutical development challenges, and recommends potential solutions.
  • Works with internal and external partners as necessary to meet formulations needs.
  • Develops safe, viable and robust formulations using pharmaceutically acceptable inactive ingredients that enable the delivery of water insoluble compounds by multiple routes of administration.
  • Conducts formulation and process technology transfers to external partner sites and monitors activities at CDMOs to meet PTC's project timelines.
  • Designs studies and conducts phase-appropriate risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
  • Conducts formulation & process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools.
  • Provides pre-formulation, formulation, and manufacturing support for drug product formulation development; and for the transfer of formulation development to contract manufacturing organizations, as necessary.
  • Maintains appropriate experimental records in laboratory notebooks.
  • Performs other tasks and assignments as needed and specified by management.

Requirements

  • This involves performing lab activities, analyzing the data, planning studies and communicating lab results to cross-functional team members and line management, and presenting results to stakeholders as required.
  • Maintains safe laboratory working conditions and maintains a steady uninterrupted supply of raw materials, reagents, supplies, and any required tools as necessary.
  • Special knowledge or skills needed and/or licenses or certificates required:
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

Nice to have

  • Special knowledge or skills and/or licenses or certificates preferred:

Skills

  • Proven understanding of physical pharmacy & engineering concepts in formulation and process development and related scale-up principles.
  • Proficiency in working with and overseeing CMOs for formulation development and manufacture for PTC projects is desirable.
  • Proficiency with Microsoft Office applications.
  • Excellent verbal and written communication skills.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Understanding of physical chemistry and physical pharmacy as they relate to concepts in preformulation and formulation.
  • Experience using electronic lab notebook.

Compensation

  • $133,100- $158,000.
  • The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
  • In addition to base salary, PTC employees are also eligible for short- and long-term incentives.
  • Expected Base Salary Range:

Benefits

  • All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
  • Minimum level of education and years of relevant work experience:
  • Familiarity with the preparation of formulations for drug discovery and clinical support by both oral and parental routes of administration.

Company info

  • Extending life's moments for children and adults living with a rare disease.
  • At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered.
  • Visit our website to learn more about our company and culture!
  • We are committed to treating all applicants fairly and avoiding discrimination.

Equal opportunity

  • PTC Therapeutics is an equal opportunity employer.
  • Click here to return to the careers page
  • We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law.
  • EEO Statement:
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