Senior Research Fellow, Formulation Development

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections where posting has real specific content. We need to parse the posting. First, we need to extract sections: - About the role: The posting includes a description of the role: "The Senior Research Fellow, Formulation Development is responsible for leading and directing formulation development and clinical supply manufacturing activities..." This is a prose description. Could be "About the role". We'll include. - Responsibilities: The "Essential Functions Primary Duties/responsibilities" list many bullet-like sentences. We'll put them in

• . - Requirements: The "Knowledge/Skills/Abilities Required" includes Minimum level of education and years of relevant work experience, special knowledge or skills needed, etc. That's requirements. - Qualifications: Might overlap with requirements. But we can separate: maybe "Qualifications" includes education/experience, while "Skills" includes abilities. However we need to avoid thin sections. The instruction: Prefer a few substantive sections over many thin ones. So we could combine Requirements and Qualifications into one? But they ask to use headings for those specific names if content exists. We need to decide. We have content for: - About the role: yes. - Responsibilities: yes. - Requirements: yes (education/experience, special knowledge/skills). - Skills: yes (many abilities like problem solving, communication, etc.) - Benefits: yes (short- and long-term incentives, medical, dental, vision, retirement savings plans). Also maybe base salary range is Pay. - Pay: yes (Expected Base Salary Range: $190,700 – $240,0200). Note there is a typo: $240,0200 (likely $240,020). We'll keep as given. - Schedule: maybe not explicit; there is Travel requirements 10-15% and Physical requirements Office/laboratory-based position. No schedule like full-time/part-time. Not given. So we should not include Schedule. We should not include headings with filler like "commensurate with experience". Not present. We need to remove boilerplate: EEO statement, application instructions, site link maybe? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should drop the EEO statement and the site link? The site link is part of "Visit our website to learn more about our company and culture! Site: www.ptcbio.com". That's maybe considered navigation? It's not boilerplate but it's a link; but we can keep as part of About the role? Probably we should drop it as it's not substantive about the role. The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. The site link is not substantive about the job; it's just a link to learn more. Could be considered boilerplate? It's not EEO but it's a promotional link. Might be considered navigation. Safer to drop it. Also drop "Job Description Summary" heading? Not needed as we are using our own headings. We need to output only HTML fragment, no markdown. Let's craft:

  About the role

  ... prose ...

  Then

  Responsibilities

  • ... each duty ...
  Then

  Requirements

  ... education/experience ...

  • ... special knowledge/skills needed ...
  Then

  Skills

  • ... abilities ...
  Then

  Benefits

  • ... short- and long-term incentives ...
  • ... medical, dental, vision, and retirement savings plans ...
  Then

  Pay

  Expected Base Salary Range: $190,700 – $240,0200.

  We need to ensure we preserve all substantive information. Let's extract details. About the role: The first paragraph: "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. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging." That's about company culture. Then "Job Description Summary The Senior Research Fellow, Formulation Development is responsible for leading and directing formulation development and clinical supply manufacturing activities that support PTC’s drug discovery and clinical development programs. This involves preclinical and clinical formulation design and selection, preformulation characterization, process development and scale up and managing external service providers for formulation development and manufacturing. The Senior Research Fellow, Formulation Development manages and/or oversees internal and external resources to address PTC’s formulation development and manufacturing requirements and related business needs. This includes accountability for ensuring the timely and successful development and manufacture of phase-appropriate formulations. Additional responsibilities include drug product process scale up, technical transfers and planning of manufacturing-related activities. The incumbent works cross-functionally and serves as the primary liaison between the Formulation team, other PTC departments, external service providers and contract manufacturers on formulation related issues. This individual also authors and reviews technical documents included in various regulatory submissions. She/He may have direct reports. The Senior Research Fellow, Formulation Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate." We can combine that into About the role paragraph. Responsibilities: The list under "Primary Duties/responsibilities". It's a long sentence with many duties separated by periods. We need to split into list items. Let's extract each duty: - Develops robust formulations and manufacturing processes for Phase I-III clinical studies and assists in their transfer to Contract Manufacturing Organizations (CMOs). - Designs studies and conducts risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development. - Conducts process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools. - Supports formulation and process technology transfers and scale up to commercial manufacturing sites. - Conducts troubleshooting of formulation & processing related challenges and recommends potential solutions. - Develops alternate formulations for current commercial products through life cycle management as required. - Collaborates with PTC's cross-functional working groups and plays a lead role in addressing formulation needs for preclinical and 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. - Establishes the formulation strategy and development plan for preformulation and formulation activities for dosage form development in close collaboration with Clinical, Regulatory, Process Chemistry, Analytical, Project Management and other PTC groups. - Leverages knowledge of traditional and enabling drug delivery technologies where applicable. - Directs and provides technical guidance and oversees formulation activities to support drug discovery and clinical programs, provides developability input in the selection of drug candidates, troubleshoots formulation & process related issues for drug products. - Evaluates third party service providers for formulation development and provides input towards their selection as necessary. - Collaborates with Business Development, Legal and Quality and facilitates the execution of service agreements. - Serves as the primary liaison with formulation development and contract manufacturing sites and with internal and external Quality Assurance groups for assigned projects. - Collaborates with CMOs and other outsourced partners to transfer manufacturing processes for drug product and to monitor cGMP batch manufacture. - Works with Clinical Supplies group to plan manufacturing campaigns for drug product. - May manage, coach and mentor direct reports. - Performs other tasks and assignments as needed and specified by management. We need to ensure we didn't miss any. Now Requirements: The "Knowledge/Skills/Abilities Required" section includes: - Minimum level of education and years of relevant work experience. PhD degree in a relevant scientific discipline and a minimum of 8 years progressively responsible experience in a pharmaceutical, biotechnology or related environment OR a Master’s degree in a relevant scientific discipline and a minimum of 10 years progressively responsible experience in a pharmaceutical, biotechnology or related environment. - 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. Demonstrated expertise in oral dosage form (e.g., tablet, capsule, solution) manufacturing and scale up. Demonstrated knowledge of cGMP. Proven problem-solving skills. Demonstrated ability to develop and deliver presentations to senior management on the current status of projects and at internal and external technical meetings on formulation-related technologies and trends, as required. Ability to influence without authority. If managing direct reports, demonstrated leadership ability and experience managing, coaching and mentoring direct reports. Provides support as needed for regulatory submissions or responses. Manages the general safe working conditions in the laboratories. Proficiency with Microsoft Office. Excellent interpersonal, 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 thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Then "Special knowledge or skills and/or licenses or certificates preferred." includes: - Experience managing and developing one or more direct reports. - Experience using electronic lab notebook. - Experience in formulation support work for Drug Discovery, Clinical Development, & Commercialization. - Track record of authorship of pertinent sections of successful regulatory submissions (INDs, CTAs, NDAs, Abbreviated New Drug Applications (ANDAs), MAAs, Investigational Medicinal Product Dossiers (IMPDs)) leading to the commercialization of drug products. - 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. - Travel requirements 10-15% - Physical requirements Office/laboratory-based position We need to decide where to put travel and physical requirements. They could be under Requirements or maybe under a separate section like "Additional Information". But we only have headings list; we could include them under Requirements as part of special knowledge/skills preferred. Or we could create a separate section "Requirements" and "Preferred Qualifications". But we only have set headings; we could put them under Requirements as part of the list. But we also have Skills section for abilities like problem solving, communication, etc. Many of those appear in both Required and Preferred. To avoid duplication, we could separate: Requirements = education/experience + special knowledge/skills required (mandatory). Skills = abilities (problem solving, communication, leadership, etc.) that are more soft skills. Preferred = maybe we could incorporate into Skills or Requirements? The instruction: Prefer a few substantive sections over many thin ones. So we could combine Requirements and Skills into one section? But they ask to use those headings if content exists. We have content for both, so we should include both. Thus: - Requirements: education/experience + mandatory special knowledge/skills (the list under "Special knowledge or skills needed and/or licenses or certificates required.") plus maybe travel/physical? Those are not mandatory but could be included. - Skills: the abilities list (problem solving, communication, ability to work independently, analytical thinker, planning, etc.) plus maybe the preferred items like experience managing direct reports, electronic lab notebook, etc. But those are more experience/skills. Could be considered Skills. We need to avoid duplication. Let's parse: From "Knowledge/Skills/Abilities Required": after education/experience, there is "Special knowledge or skills needed and/or licenses or certificates required." Then a list of