Us PTC Therapeutics

Us PTC Therapeutics

Director, Formulation Development

USA - New Jersey - Bridgewater · Director · Contract

Sponsorship not specified$10k-$15kDetected 8 days ago
Project ManagementBusiness DevelopmentClinical TrialsGMPAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingTime ManagementMentoringPublic Speaking

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

  • Collaborates with PTC's cross-functional working groups and plays a lead role in addressing formulation needs for preclinical & clinical studies and establishing the strategy and development plan for preformulation, formulation, and process development activities.
  • Leverages knowledge of physical pharmacy, biopharmaceutics, formulation and process design, drug delivery technologies where applicable.
  • Directs and provides technical guidance and oversees formulation activities to support drug discovery & clinical programs, provides developability input in the selection of drug candidates, troubleshoots formulation & process related issues for drug products.
  • Collaborates with Business Development, Legal and Quality and facilitates the execution of service agreements.
  • Collaborates with CMOs and other outsourced partners to transfer manufacturing processes for drug product and to monitor cGMP batch manufacture.
  • May manage, coach and mentor direct reports.
  • Performs other tasks and assignments as needed and specified by management.
  • Provides support as needed for regulatory submissions or responses.
  • Manages the general safe working conditions in the laboratories.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Requirements

  • Special knowledge or skills needed and/or licenses or certificates required:
  • Strong understanding of physical pharmacy, biopharmaceutics, drug delivery technologies and experience in the formulation development of small molecules including oral dosage forms.
  • 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

  • Demonstrated expertise in oral dosage form (e.g., tablet, capsule, solution) manufacturing and scale up.
  • Demonstrated knowledge of cGMP.
  • Proven problem-solving skills.
  • Ability to influence without authority.
  • If managing direct reports, demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
  • Proficiency with Microsoft Office.
  • Excellent interpersonal, verbal and written communication skills.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Experience using electronic lab notebook.
  • Experience providing responses to questions from health authorities with respect to regulatory submissions.
  • Ability to work cross functionally (internally and externally) on strategic, tactical and technical matters.

Compensation

  • $215,200 - $270,900.
  • 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:

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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