Jobs · Marketing · Massachusetts

Associate Director, Formulation and Drug Product Development

BioSpace · Waltham, MA · 4 wk ago
On-siteMarketing$159k–$195k/yrFull-time
We need to output HTML fragment with sections: Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We have company overview and role summary. We need to decide sections. We have "Company Overview" maybe not needed as heading? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. So we can have sections like About the role (maybe from Role Summary), Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to preserve all substantive info, remove boilerplate (EEO, etc). Also remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. We need to include Pay section because posting states MA Pay Range $159,000 - $195,000USD. So include Pay. Schedule: posting says "This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week." That's schedule info. So we can include Schedule section. Benefits: Not mentioned. So we should not include Benefits section. Qualifications vs Requirements vs Skills: The posting includes "Education And Skills Requirements" with PhD etc. Also "Strong Experience And Knowledge Of CGMP Manufacturing Requirements." Also list of skills. We can combine into Requirements and Skills sections perhaps. We need to avoid filler like "commensurate with experience". Not present. We need to output only HTML fragment, no /, no markdown fences. We need to use
  • for any list of duties/requirements/benefits, and

    for prose. Thus we need to parse content. Let's extract sections: About the role: Could be from Role Summary and Company Overview? The role summary: "The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials. This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week." We could put that in About the role. Responsibilities: List bullet points from "Primary Responsibilities Include". Those are multiple sentences each starting with a verb. We'll turn each into

  • . Requirements: Education and experience: "PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience." Also maybe "Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables." That's more like requirement. Also "Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities." Also "Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing." Also "Strong Experience And Knowledge Of CGMP Manufacturing Requirements." Also "Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner." Also "Experience managing complex schedules and priorities in a dynamic biotech environment." Also "Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs)." Also "Collaborative work style to be part of a team to identify process gaps and constructively develop solutions." Also "Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships." Also "Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors." These could be split into Requirements (education/experience) and Skills (soft skills, technical). But we can combine. Qualifications: maybe same as Requirements. But we need to avoid duplicate sections. The instruction: Prefer a few substantive sections over many thin ones. So we could have sections: About the role, Responsibilities, Requirements (including education, experience, technical expertise), Skills (maybe soft skills), Pay, Schedule. But we need to ensure we don't create sections with filler. All have content. Let's decide: - About the role: prose from role summary. - Responsibilities: list of bullet points. - Requirements: education, years experience, proven experience in clinical drug product formulation development, expertise in sterile fill-finish, understanding of analytical techniques, understanding of external manufacturing operations, knowledge of CGMP. - Skills: strategic thinker, sense of urgency, managing complex schedules, ability to work across functions, collaborative work style, excellent communication, resilient, fast-paced, supporting multiple programs/vendors. - Pay: the pay range. - Schedule: onsite 4-5 days/week, Waltham, MA, not remote. We should not include Benefits. Now format. We need to use

    for each section heading. Inside sections, use

    for prose,

    • for lists. For About the role: prose, maybe one or two paragraphs. We'll put in

      . For Responsibilities: list each bullet. For Requirements: list each bullet. For Skills: list each bullet. For Pay: maybe a

      with the range. For Schedule:

      with details. Make sure to preserve all substantive info: include location Waltham, MA, onsite 4-5 days/week, not remote. Also include that role is based in Waltham, MA without possibility of being remote. Physical presence onsite expected 4-5 days/week. Now let's extract bullet points exactly. Primary Responsibilities Include: - Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing. - Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts. - Build and enhance internal capabilities for formulation development in the laboratory. - Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3). - Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada). - Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation. - Responsible for driving execution of the formulation development plan at CDMO (PO through delivery). - Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration. We'll keep these as list items. Now Requirements bullets: From "Education And Skills Requirements": - PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. - Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables. - Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities. - Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing. - Strong Experience And Knowledge Of CGMP Manufacturing Requirements. We could also include "Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner." but that seems more skill. But we can keep that in Skills. Now Skills bullets: - Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner. - Experience managing complex schedules and priorities in a dynamic biotech environment. - Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs). - Collaborative work style to be part of a team to identify process gaps and constructively develop solutions. - Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships. - Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors. Now Pay: "MA Pay Range $159,000 - $195,000USD The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills." We can include that as prose. Now Schedule: "This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week." We'll put that. Now we need to ensure we don't include any boilerplate like EEO etc. Remove that. Now produce HTML. We'll start with

      About the role

      then

      ...

      Then

      Responsibilities

      • ...
      • ...
      Then

      Requirements

        ...
      Then

      Skills

        ...
      Then

      Pay

      ...

      Then

      Schedule

      ...

      Make sure no extra whitespace issues. Let's craft the prose for About the role: combine role summary sentences. "The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials. This role is based in Waltham, MA without the possibility of being a remote role. Physical presence onsite is expected on 4-5 days/week." But note schedule info also appears in Schedule section; we might duplicate. However we can keep schedule info only in Schedule section, not in About the role. The About the role could exclude the schedule sentence to avoid duplication. But we need to preserve all substantive info; duplication is okay? The instruction: remove duplicated lines. So we should avoid duplicating the same sentence in two places. So we should not repeat the schedule info in About the role if we have a Schedule section. So About the role should exclude the location and schedule sentences. Let's keep About the role focusing on accountability and partnership. Thus About the role prose: "The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials." Now Schedule section will contain location and onsite expectation. Now ensure we didn't miss any other substantive info: The company overview maybe not needed as a section; but we could incorporate into About the role? The instruction says we can use About the role for section heading. The company overview is not about the role but about company. Could we include it in About the role? Might be considered filler but it's substantive about company. However the instruction: Use

      for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid adding other headings, but we should prefer those headings. The company overview could be placed under About the role

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