Jobs · Management · New Jersey

Manufacturing Lead Operator, Aseptic Process

Legend Biotech · Raritan, NJ · 2 wk ago
On-siteManagement$84k/yrFull-time
We need to output HTML fragment with sections for headings: 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. Must preserve all substantive info, no invented or summarized away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. Also remove EEO statement etc. Also remove work authorization? Possibly not boilerplate but it's still a requirement; but it's not a section heading; we can embed in Requirements maybe? The instruction: "Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it." So we can include work auth as a short paragraph maybe under Requirements or separate? But we should not create a heading for it unless it's a section heading like "Work Authorization". Not listed as allowed headings; we can embed in a paragraph under Requirements or maybe a separate

before sections. The instruction: Output ONLY the HTML fragment — no /, no markdown code fences. We need to decide sections: About the role (role overview), Responsibilities (key responsibilities), Requirements (requirements), Qualifications (maybe overlapping with requirements; but we can combine? The instruction: Prefer a few substantive sections over many thin ones. So we could have About the role, Responsibilities, Requirements, Benefits, Pay. Possibly Skills could be part of Requirements. Qualifications maybe same as Requirements. We'll include sections that have distinct content. Let's extract content: About the role: The role overview paragraph: "Legend Biotech is seeking a Manufacturing Lead Operator, Aseptic Process as part of the Manufacturing & Operations team based in Raritan, NJ. Role Overview CAR-T products and processes are a novel cell therapy, and thus are well supported by a degree in engineering or a related field where not only are valuable scientific and technical skills learned, but also the ability to connect ideas and analyze complex problems. This role will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule." We need to preserve all substantive info. So we can put that in

About the role

then

...

. Responsibilities: The "Key Responsibilities" block is a long paragraph with many sentences. We need to break into list items? The instruction: Use
  • for any list of duties/requirements/benefits. The responsibilities are not explicitly a list but we can treat each sentence as a duty? Might be better to keep as

    but instruction says use

    • for any list of duties/requirements/benefits. Since responsibilities are a list of duties, we should convert to list items. However we must preserve all info; we can split sentences into
    • . Let's identify each duty sentence: From the text after "Key Responsibilities": "This individual establishes effective time management skills and prioritization of various job requirements, supported by a degree in engineering or related field to better analyze and execute effective decision during critical times for positive outcomes." "To offer support in development of CAR-T manufacturing processes, this individual requires an understanding of the underlying technical requirements of the process and product must have, where complex risk analyses and change management techniques are utilized to establish a high quality and safe drug product through periods of improvement." "This individual with strong scientific and technical background, will support the development of manufacturing processes, and will work with technical support and engineering personnel to drive continuous improvements and implement corrective and preventative actions within cell therapy Technical Operations." "This individual will be responsible for general production floor oversight of Legend Biotech's BCMA CAR-T Cell Therapy Operations in both ISO 5 and ISO 7 environments, and support floor activities with extensive knowledge of CAR-T cell therapy processes, GMP quality systems and their regulatory requirements." "This individual requires prior in-depth knowledge of lab sciences, cellular lab techniques, and data analysis to complete daily responsibilities and assess the impacts and consequences in relation to other process areas, without jeopardizing quality, accuracy and efficiency." "This individual will perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) performed within specialized BSL2+ ISO 5 and ISO 7 cleanroom environments, according to standard operating procedures and batch records, while recording production data and information in a clear, concise format." "This individual will require critical thinking and troubleshooting skills to respond to patient specific product issues to ensure continuous flow of operations, while performing tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements within particular manufacturing processes." "Establish key stakeholder relationships with internal and external stakeholders, as collaboration and understanding across functional stakeholders are essential to maintaining this dynamic, fast-paced environment, which is CAR-T manufacturing" "With a degree in engineering and related scientific or technical field, this individual must have the ability to interact with all levels within the organization through scientific and technical expertise" "Strong communicative skills and a broad technical understanding of complex systems are must haves, to build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional and matrixed team to successful manufacture CAR-T product in a safe and high quality manner." We need to ensure we didn't miss any. Also there is a sentence: "This individual establishes effective time management skills and prioritization of various job requirements, supported by a degree in engineering or related field to better analyze and execute effective decision during critical times for positive outcomes." That's a duty. Now Requirements: The "Requirements" block: "Bachelor’s degree in life science/engineering, or related field or equivalent experience required. A minimum of 2 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, maintenance, quality, testing, or engineering is required. Prior experience in an aseptic manufacturing environment is preferred. An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment. Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures. Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products. Ability to lift a minimum of 50 lbs and stand for a long period of time. Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records. Ability to handle human derived materials in BSL-2 cleanroom facility. Physical dexterity sufficient to use computers and documentation. Ability to accommodate shift work including evenings and weekends as required by the manufacturing process. Ability to accommodate unplanned overtime on little to no prior notice. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses. Color Perception both eyes 5 slides out of 8. AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use." We need to preserve all. We'll put these as
      • items. Qualifications: Might be overlapping with Requirements; but we could treat Requirements as qualifications. Since we have both headings possible, but we should avoid thin sections. We could combine Requirements and Qualifications into one section called "Requirements". Or we could have "Requirements" and "Qualifications" but they'd be similar. Better to have one section. Skills: Could be extracted from responsibilities and requirements but we might not need separate. Benefits: The "Benefits and Paid Time Off:" block: "Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work." Also note: "Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech." That's also part of benefits. Pay: "The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Pay Range (Base Pay): $83,711 USD - $109,870 USD" Schedule: Not explicitly mentioned except shift work: "Ability to accommodate shift work including evenings and weekends as required by the manufacturing process." and "Job duties will be performed within a team based on an assigned production shift schedule." That's schedule info. So we can include a Schedule section with that info. We must not include boilerplate: EEO statement, Work Authorization & Employment Eligibility, Privacy notice, etc. Remove those. Also remove duplicated lines: There's duplicate "Physical dexterity sufficient to use computers and documentation." appears twice in requirements; we should keep only one? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Duplicate lines are part of the posting; we should keep them? It says remove duplicated lines. So we should deduplicate. So we need to remove duplicate lines. Let's identify duplicates: In requirements list we have: - Ability to lift a minimum of 50 lbs and stand for a long period of time. - Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records. - Ability to handle human derived materials in BSL-2 cleanroom facility. - Physical dexterity sufficient to use computers and documentation. - Ability to accommodate shift work including evenings and weekends as required by the manufacturing process. - Ability to accommodate unplanned overtime on little to no prior notice. - Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals - Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses. - Color Perception both eyes 5 slides out of 8. - AI Literacy: ... Also earlier we had "Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records." and later "Physical dexterity sufficient to use computers and documentation." These are similar but not exact duplicates; one mentions vision and hearing, the other just physical dexterity. Not duplicate. However there is also "Physical dexterity sufficient to use computers and documentation." appears only once? Actually appears twice? Let's check: In the requirements block we saw: "Ability to lift a minimum of 50 lbs and stand for a long period of time. Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records. Ability to handle human derived materials in BSL-2 cleanroom facility. Physical dexterity sufficient to use computers and documentation. Ability to accommodate shift work including evenings and weekends as required by the manufacturing process. Ability to accommodate unplanned overtime

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