Jobs · Management · North Carolina

Lead, Manufacturing - Cell Culture (Nights)

Biogen · Triangle, NC · 1 mo ago
Management$33.17–$43.27/hrFull-time
We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must not include Job ID etc. Must remove boilerplate. Must preserve all substantive info. We need to parse the posting. Key sections: - About This Role: description of Manufacturing Lead responsibilities overview. Could be "About the role". Use

About the role

then

with that paragraph. - Responsibilities: list of duties (the bullet list after "The Manufacturing Lead responsibilities include but are not limited to:" and subsequent bullet points). Should be

  • each. - Requirements: maybe "Who You Are" describing desired traits. Could be "Requirements" or "Qualifications". The posting includes "Who You Are" describing agile self-motivated leader etc. Also "Required Skills for Lead, Manufacturing:" includes pay range and then list of education/experience combos. Also "Preferred Skills". So we need to separate. We have sections: Pay: there is "$33.17 - $43.27 Pay Range" and later "The base compensation range for this role is: $33.17-$43.27". So we have pay info. Must include Pay section only if real specific content. Yes we have numbers. Schedule: shift details: "Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. Shift Details: This role follows a 2-2-3 calendar rotation on days (6:00 PM – 6:00 AM ET) Internal Shift Details: Red Nights rotating schedule". So schedule info present. Should include Schedule section. Benefits: there is a Benefits paragraph listing many benefits. So include Benefits section. Qualifications: maybe combine education/experience requirements. Could be "Qualifications". The posting includes "The following combination of academic and/or relevant experience may be considered:" with bullet list of combos. Also "Demonstrated experience leading manufacturing activities..." etc. Those could be Requirements or Qualifications. We need to decide. Skills: there is "Required Skills for Lead, Manufacturing:" then list of required skills (the combos). Also "Preferred Skills". So we could have Skills section for required and preferred? But we must not create thin sections. Perhaps combine Required Skills and Preferred Skills into Skills section. However we also have Requirements (maybe the "Who You Are" traits). Let's think. We need to follow instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can use those exact headings. We need to include a section only when posting has real specific content for it. So we need to decide which of those headings have content. - About the role: yes (About This Role paragraph). - Responsibilities: yes (list of duties). - Requirements: maybe the "Who You Are" traits (agile, self-motivated leader, etc.) could be considered requirements. Also the "Demonstrated experience leading manufacturing activities..." etc. That seems like requirements. So we can put those under Requirements. - Qualifications: the education/experience combos (Bachelor’s degree..., BioWorks Certificate..., High School Diploma...). That seems qualifications. So we can put under Qualifications. - Skills: the required skills list (the combos? Actually those are qualifications/experience. The required skills list includes "Demonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment" etc. That's more like skills. Also "Preferred Skills" list. So we can put under Skills. - Benefits: yes. - Pay: yes. - Schedule: yes. Thus we will have all eight sections. We must not include filler like "commensurate with experience". Not present. We need to preserve all substantive information; do not invent or summarize away detail. So we need to include all details from each section. Let's extract content precisely. About This Role paragraph: "The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment, including operation of process equipment, execution of validation protocols, and revision of cGMP documents while ensuring compliance to cGMP and maintenance of equipment and facilities. This position works closely with the Shift Manager to coordinate critical activities collaboratively and utilize resources efficiently. This is a key preparatory role for the Manufacturing Shift Manager position." We'll put that in

    . Responsibilities list: after "The Manufacturing Lead responsibilities include but are not limited to:" then bullet points: - Execute cell culture manufacturing processing steps and/or manufacturing support activities while monitoring performance against the batch record, electronic systems, and process controls. - Serve as a Subject Matter Expert (SME) for multiple upstream unit operations and lead critical process activities. - Coordinate shift activities in partnership with the Shift Manager, including production execution, validation activities, and project support. - Plan resources effectively and ensure thorough communication during shift changes. - Document, record, and verify cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. - Develop and/or revise documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. - Ensure real-time review requirements are met. - Train, mentor, and support Manufacturing Associates while managing personal training requirements. - Observe performance of employees, provide timely and targeted coaching for employees, and share feedback with the Shift Manager at mid-year and year-end. - Initiate and actively participate in deviations investigations, develop and implement corrective and preventative actions as required. - Lead and/or actively participate in troubleshooting. - Serves as possible potential SME for audits and tours. We need to keep each as

  • . Ensure we keep punctuation. Requirements: from "Who You Are" paragraph: "Our Cell Culture Manufacturing team is looking for an agile, self-motivated leader who thrives in a fast-paced manufacturing environment. You take ownership of your work, act with integrity, and are committed to maintaining the highest standards of safety, quality, and compliance. You bring strong technical expertise in upstream manufacturing processes while supporting the development of others through coaching, training, and collaboration. Success in this role requires excellent communication skills, attention to detail, sound decision making, and the ability to lead by example working across teams and shifts." That's the requirements. Also there is "Demonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment" etc. Actually that appears under "Required Skills for Lead, Manufacturing:" after the pay range? Let's see: The text: "Required Skills for Lead, Manufacturing: $33.17 - $43.27 Pay Range The following combination of academic and/or relevant experience may be considered:Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experienceA BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 year of direct experienceA High School Diploma (or equivalent) and at minimum of 5 years of direct experienceDemonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environmentDemonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP)Experience supporting Upstream cell culture manufacturing operations in a pharmaceutical, biotechnology, or related regulated manufacturing environmentExperience working in an aseptic or cleanroom environmentExperience with manufacturing systems such as Trackwise, Delta V, Syncade, LIMS, or similar systems Preferred Skills Prior cell culture manufacturing experience in a leadership capacityExperience with bioreactor operations, Media Preparation, Harvest operations, Aseptic Cell Expansion, and other upstream manufacturing processes" So the required skills list includes those bullet-like items after the education combos. Actually the formatting is messy. Let's parse: "Required Skills for Lead, Manufacturing: $33.17 - $43.27 Pay Range" Then "The following combination of academic and/or relevant experience may be considered:" then three combos (Bachelor's..., BioWorks..., High School...). Then after that, there is no punctuation but then "Demonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment" etc. Those seem like required skills (maybe part of Requirements). Then "Preferred Skills" list. Thus we need to allocate: - Qualifications: the three education/experience combos. - Skills: the required skills list (Demonstrated experience..., Demonstrated ability..., Experience supporting..., Experience working..., Experience with manufacturing systems...). Plus maybe also the "Preferred Skills" list. But we also have a separate Skills heading; we could put both required and preferred under Skills, maybe separate subheadings? But instruction only says use

    for section headings, not subheadings. Could we include two
      under Skills heading, one for required, one for preferred? That's okay. Thus Skills section will contain: Required skills: - Demonstrated experience leading manufacturing activities, coordinating shift work, and training associates in a cGMP environment - Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP) - Experience supporting Upstream cell culture manufacturing operations in a pharmaceutical, biotechnology, or related regulated manufacturing environment - Experience working in an aseptic or cleanroom environment - Experience with manufacturing systems such as Trackwise, Delta V, Syncade, LIMS, or similar systems Preferred skills: - Prior cell culture manufacturing experience in a leadership capacity - Experience with bioreactor operations, Media Preparation, Harvest operations, Aseptic Cell Expansion, and other upstream manufacturing processes Now Requirements section: we already used the "Who You Are" paragraph. Should we also include the "Demonstrated experience..." etc? But we moved those to Skills. However the "Demonstrated experience leading manufacturing activities..." could be considered a requirement as well. But we already used it under Skills required. Might be okay to keep it there. The "Who You Are" paragraph covers soft skills. The "Demonstrated experience..." is more concrete requirement. Could also go under Requirements. But we need to avoid duplication. The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include that info somewhere. If we put it under Skills, it's still included. That's fine. Thus Requirements will be just the "Who You Are" paragraph. Qualifications: the three combos. We need to format them as list items. Now Benefits: paragraph listing many benefits. We'll keep as

      with the list maybe as

        but the instruction: Use
        • for any list of duties/requirements/benefits. So benefits list should be
          • . The benefits paragraph includes a sentence: "In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:" then a list separated by commas. We should turn each benefit into
          • . Let's extract: - Medical, Dental, Vision, & Life insurances - Fitness & Wellness programs including a fitness reimbursement - Short- and Long-Term Disability insurance - A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) - Up to 12 company paid holidays + 3 paid days off for Personal Significance - 80 hours of sick time per calendar year - Paid Maternity and Parental Leave benefit - 401(k) program participation with company matched contributions - Employee stock purchase plan - Tuition reimbursement of up to $10,000 per calendar year - Employee Resource Groups participation We need to keep the exact phrasing. Ensure we don't lose any. Pay: we have "$33.17 - $43.27 Pay Range" and later "The base compensation range for this role is: $33.17-$43.27

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