Associate Director, Device Development
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should use those exact headings if content exists. We need to decide which sections to include.
We have a summary about the role: "Summary BioMarin is seeking an experienced and motivated Associate Director..." That's about the role. So we can put that under About the role
with paragraphs.
Responsibilities: we have a list under "Responsibilities". Use - .
Requirements: maybe "Experience Required Skills:" and "Desired Skills" and "EDUCATION". Could combine into Requirements and Qualifications? The allowed headings: Requirements, Qualifications, Skills. We need to decide.
We have "Experience Required Skills:" which is basically required experience/skills. Also "Desired Skills". Also "EDUCATION". Could map:
- Requirements: include the "Experience Required Skills:" bullet points (maybe as list). Also maybe "Desired Skills" could go under Skills section.
- Qualifications: maybe include EDUCATION.
- Skills: include Desired Skills.
But we must not create sections with filler. Ensure we have real content.
Also we have "CONTACTS" maybe not needed.
"ONSITE, REMOTE, OR FLEXIBLE Hybrid. 3 days a week in Novato" => schedule info. So we can create
Schedule
with that content.
Travel Required: maybe also schedule? Could be part of Schedule or separate? Not in allowed headings. Could drop.
We must not include boilerplate like EEO, etc.
We must preserve all substantive information; do not invent or summarize away detail. So we need to keep details like specific responsibilities bullet points, required skills bullet points, desired skills bullet points, education, hybrid schedule, travel up to 10%, contacts? The contacts maybe not needed but it's substantive; but we don't have a heading for contacts. Could we include as a paragraph under maybe "About the role"? But that would be adding unrelated content. The instruction: "Prefer a few substantive sections over many thin ones." We could add a section "Contacts" but not allowed heading. So maybe we drop contacts? But that would be removing substantive info, which is prohibited: "Preserve ALL substantive information". So we need to keep contacts somewhere. Could we put them under a generic without heading? The instruction says output ONLY the HTML fragment, we can include paragraphs not under headings? It didn't forbid extra paragraphs outside sections. It says use
for section headings (list). It doesn't say we cannot have other headings, but we should follow the pattern. Probably we can include a
for contacts without a heading. That's acceptable.
Similarly, "Who We Are" and "About Technical Operations" could be combined into About the role section as paragraphs.
We need to ensure we don't repeat job title as heading.
We must not include cookie/navigation/legal/EEO etc. Remove duplicated lines.
Let's extract substantive content:
Who We Are BioMarin is a leading rare disease biotechnology company ... (paragraph). About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Summary BioMarin is seeking an experienced and motivated Associate Director to join our Combination Products and Medical Devices team. This role is pivotal, encompassing strategic and technical responsibilities. This role provides an opportunity to leverage your device development expertise to develop transformational drug delivery technologies for BioMarin to meet our long-term aspirations. To deliver on this, the candidate must have a proven track record of success working cross-functionally at senior levels and have experience engaging with all functions involved with device development. The ideal candidate will exhibit a strong technical background in drug delivery systems, deep experience in leading cross-functional device team leadership, including experience in combination product development, device/combination product manufacturing operations, and drug product development, with a proven track record of successful device/combination product development and commercialization. This role requires managing senior level stakeholders, a deep understanding of ISO requirements, medical device regulations, and experience in combination products/device development from inception through commercialization and life cycle management. This role demands a high level of expertise in systems engineering fundamentals, mechanical product and process design as well as collaborative operation within a cross functional matrix team environment.
Responsibilities Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support. As needed, lead technology development of unique drug delivery technologies.Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions.Lead external device vendor engagement and strategic oversight of externally developed device technologies.As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices. Lead product and process improvement related to on market products.Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables.Prepare and present reports to senior management on project status, risks, and opportunities.Mentor engineers and scientists within the department.Knowledge of global regulatory requirements and industry standards.Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.Other duties as assigned.
Experience Required Skills: Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices.Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders.Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable.Deep expertise in design controls.Experience working with contract manufacturers.Exposure to human factors engineering.Working with regulatory agencies and ensuring compliance with industry standards.Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide).
Desired Skills Worked at large-mid sized pharma and/or biotechnology companies focused on developing parenteral combination products. Led cross-functional device teams and commercialized prefilled syringes, autoinjectors, and/or pen devices Worked with industry standard primary container technologies like prefilled syringes, cartridges, and vials Experience with lyophilized product related drug delivery
EDUCATION Bachelor’s degree in engineering, Life Sciences, or a related field. Advanced degree preferred.
CONTACTS Device engineers, device quality, device regulatory, external manufacturing, drug product formulation scientists, supply chain engineers, asset team members like clinical and commercial.
ONSITE, REMOTE, OR FLEXIBLE Hybrid. 3 days a week in Novato
Travel Required Up to 10% domestic and international travel
Now we need to map to sections.
We'll create:
About the role
Who We Are BioMarin is a leading rare disease biotechnology company ... About Technical Operations BioMarin’s Technical Operations group is responsible ... Summary BioMarin is seeking an experienced and motivated Associate Director ... (the whole summary paragraph).
But we might split into two paragraphs: one for Who We Are + About Technical Operations, another for Summary. That's fine.
Responsibilities
- ... each responsibility as separate li. Need to split the responsibilities text into items. The responsibilities paragraph is a long sentence with multiple statements separated by periods. We can split at each period that starts a new responsibility. Let's identify:
- Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support.
- As needed, lead technology development of unique drug delivery technologies.
- Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions.
- Lead external device vendor engagement and strategic oversight of externally developed device technologies.
- As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices.
- Lead product and process improvement related to on market products.
- Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables.
- Prepare and present reports to senior management on project status, risks, and opportunities.
- Mentor engineers and scientists within the department.
- Knowledge of global regulatory requirements and industry standards.
- Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.
- Other duties as assigned.
We'll make each a
- .
Requirements
We could put Experience Required Skills as list.
Qualifications
Education.
Skills
Desired Skills list.
Schedule
Hybrid. 3 days a week in Novato
Travel maybe also under Schedule? Could add another sentence: "Travel Required Up to 10% domestic and international travel". Could be part of Schedule section as another paragraph.
We also need to include Contacts somewhere. Could add a under maybe "About the role" or separate section? There's no heading for Contacts. Could we add a
Contacts
? Not in allowed list but maybe allowed? The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive list? It says "use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are the allowed headings. So we should not create other headings. So we need to embed Contacts somewhere else, maybe as a paragraph under About the role or under Responsibilities? But it's not about role. Could add a
after the sections without heading. That's permissible as it's not a heading. The instruction didn't forbid extra paragraphs outside headings. It said "Use
for section headings ... Use - for any list ... and
for prose." So we can have
anywhere.
Thus after sections we can add a
for Contacts.
Now ensure we don't include boilerplate like EEO etc. We removed.
Now produce HTML fragment.
Let's craft.
We'll need to escape any HTML special characters? Not needed.
Let's write:
About the role
Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fab
Schedule
with that content. Travel Required: maybe also schedule? Could be part of Schedule or separate? Not in allowed headings. Could drop. We must not include boilerplate like EEO, etc. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep details like specific responsibilities bullet points, required skills bullet points, desired skills bullet points, education, hybrid schedule, travel up to 10%, contacts? The contacts maybe not needed but it's substantive; but we don't have a heading for contacts. Could we include as a paragraph under maybe "About the role"? But that would be adding unrelated content. The instruction: "Prefer a few substantive sections over many thin ones." We could add a section "Contacts" but not allowed heading. So maybe we drop contacts? But that would be removing substantive info, which is prohibited: "Preserve ALL substantive information". So we need to keep contacts somewhere. Could we put them under a genericwithout heading? The instruction says output ONLY the HTML fragment, we can include paragraphs not under headings? It didn't forbid extra paragraphs outside sections. It says use
for section headings (list). It doesn't say we cannot have other headings, but we should follow the pattern. Probably we can include a
for contacts without a heading. That's acceptable. Similarly, "Who We Are" and "About Technical Operations" could be combined into About the role section as paragraphs. We need to ensure we don't repeat job title as heading. We must not include cookie/navigation/legal/EEO etc. Remove duplicated lines. Let's extract substantive content: Who We Are BioMarin is a leading rare disease biotechnology company ... (paragraph). About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Summary BioMarin is seeking an experienced and motivated Associate Director to join our Combination Products and Medical Devices team. This role is pivotal, encompassing strategic and technical responsibilities. This role provides an opportunity to leverage your device development expertise to develop transformational drug delivery technologies for BioMarin to meet our long-term aspirations. To deliver on this, the candidate must have a proven track record of success working cross-functionally at senior levels and have experience engaging with all functions involved with device development. The ideal candidate will exhibit a strong technical background in drug delivery systems, deep experience in leading cross-functional device team leadership, including experience in combination product development, device/combination product manufacturing operations, and drug product development, with a proven track record of successful device/combination product development and commercialization. This role requires managing senior level stakeholders, a deep understanding of ISO requirements, medical device regulations, and experience in combination products/device development from inception through commercialization and life cycle management. This role demands a high level of expertise in systems engineering fundamentals, mechanical product and process design as well as collaborative operation within a cross functional matrix team environment. Responsibilities Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support. As needed, lead technology development of unique drug delivery technologies.Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions.Lead external device vendor engagement and strategic oversight of externally developed device technologies.As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices. Lead product and process improvement related to on market products.Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables.Prepare and present reports to senior management on project status, risks, and opportunities.Mentor engineers and scientists within the department.Knowledge of global regulatory requirements and industry standards.Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.Other duties as assigned. Experience Required Skills: Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices.Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders.Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable.Deep expertise in design controls.Experience working with contract manufacturers.Exposure to human factors engineering.Working with regulatory agencies and ensuring compliance with industry standards.Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide). Desired Skills Worked at large-mid sized pharma and/or biotechnology companies focused on developing parenteral combination products. Led cross-functional device teams and commercialized prefilled syringes, autoinjectors, and/or pen devices Worked with industry standard primary container technologies like prefilled syringes, cartridges, and vials Experience with lyophilized product related drug delivery EDUCATION Bachelor’s degree in engineering, Life Sciences, or a related field. Advanced degree preferred. CONTACTS Device engineers, device quality, device regulatory, external manufacturing, drug product formulation scientists, supply chain engineers, asset team members like clinical and commercial. ONSITE, REMOTE, OR FLEXIBLE Hybrid. 3 days a week in Novato Travel Required Up to 10% domestic and international travel Now we need to map to sections. We'll create:
About the role
Who We Are BioMarin is a leading rare disease biotechnology company ... About Technical Operations BioMarin’s Technical Operations group is responsible ... Summary BioMarin is seeking an experienced and motivated Associate Director ... (the whole summary paragraph).
But we might split into two paragraphs: one for Who We Are + About Technical Operations, another for Summary. That's fine.Responsibilities
- ... each responsibility as separate li. Need to split the responsibilities text into items. The responsibilities paragraph is a long sentence with multiple statements separated by periods. We can split at each period that starts a new responsibility. Let's identify: - Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support. - As needed, lead technology development of unique drug delivery technologies. - Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions. - Lead external device vendor engagement and strategic oversight of externally developed device technologies. - As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices. - Lead product and process improvement related to on market products. - Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables. - Prepare and present reports to senior management on project status, risks, and opportunities. - Mentor engineers and scientists within the department. - Knowledge of global regulatory requirements and industry standards. - Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities. - Other duties as assigned. We'll make each a
- .
Requirements
We could put Experience Required Skills as list.Qualifications
Education.Skills
Desired Skills list.Schedule
Hybrid. 3 days a week in Novato
Travel maybe also under Schedule? Could add another sentence: "Travel Required Up to 10% domestic and international travel". Could be part of Schedule section as another paragraph. We also need to include Contacts somewhere. Could add aunder maybe "About the role" or separate section? There's no heading for Contacts. Could we add a
Contacts
? Not in allowed list but maybe allowed? The instruction says usefor section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It gives examples but not exclusive list? It says "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are the allowed headings. So we should not create other headings. So we need to embed Contacts somewhere else, maybe as a paragraph under About the role or under Responsibilities? But it's not about role. Could add a
after the sections without heading. That's permissible as it's not a heading. The instruction didn't forbid extra paragraphs outside headings. It said "Use
for section headings ... Use
- for any list ... and
for prose." So we can have
anywhere. Thus after sections we can add a
for Contacts. Now ensure we don't include boilerplate like EEO etc. We removed. Now produce HTML fragment. Let's craft. We'll need to escape any HTML special characters? Not needed. Let's write:
About the role
Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fab
- for any list ... and