Manufacturing Associate IV / V, Purification (Nights)
About the role
: include description of 24/7, shifts, location, focus downstream, mission, etc. Could also include "Who You Are" as part of this? Might be okay. -Responsibilities
: the "What You’ll Do" bullet list. -Requirements
: education/experience combos for IV and V (maybe combine both levels). Could list as bullet points. -Qualifications
: the specific competencies: cGMP experience, SOPs/GDP, aseptic/cleanroom, process automation, pipetting. -Skills
: maybe we could list technical skills like DeltaV, LIMS, etc. But that's already in qualifications. Could combine. Better to follow typical: Requirements = education/experience; Qualifications = skills/competencies; Skills = maybe not needed. But we need to include only if real content. We have content for both Requirements and Qualifications. For Skills we might not have distinct content beyond what's in Qualifications. Could omit Skills section. Pay: include Pay section with ranges. Benefits: include Benefits section. Schedule: include Schedule section with shift details. We must not include headings with filler. So we will output:About the role
... (combined description)
Responsibilities
- ... each bullet
Requirements
- ... combos for IV and V
Qualifications
- ... cGMP, SOPs/GDP, aseptic/cleanroom, process automation, pipetting
Pay
... base compensation range etc.
Benefits
- ... benefits list
Schedule
... shift details
We must ensure we preserve all substantive information. Let's extract. About the role content: - 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 nights (6:00 PM – 6:00 AM ET) Internal Shift Details: Black Nights rotating schedule Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). This Role’s Primary Focus Is Downstream (Purification) Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance - Who You Are: You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential. We can combine. Responsibilities bullet list: - Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs) - Document and record all cGMP data & information (including deviations) for processing steps and equipment activities - Create and revise key documentation like batch records, SLRs, and equipment logbooks - Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, etc.) - Help maintain a clean and safe work environment, always focusing on audit readiness of process areas - Be a team player and leader; always showing up to contribute your energy and focus - Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members Requirements (education/experience combos): For Manufacturing Associate IV: - Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 2 years of direct experience - A BioWorks Certificate or associate's degree, STEM preferred and at minimum 2.5 year of direct experience - A High School Diploma (or equivalent) and at minimum of 3 years of direct experience For Manufacturing Associate V: - Bachelor’s degree from an accredited college or university, STEM preferred and at minimum 4 years of direct experience - A BioWorks Certificate or associate's degree, STEM preferred and at minimum 4.5 years of direct experience - A High School Diploma (or equivalent) and at minimum of 5 years of direct experience Also note: "Previous experience in a cGMP environment" etc are qualifications. Qualifications: - Previous experience in a cGMP environment - Demonstrated ability to follow Standard Operating Procedures (SOPs) and adhere to Good Documentation Practices (GDP) - Experience working in an aseptic or cleanroom environment - Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.) - Previous pipetting experience in a laboratory or manufacturing environment preferred Pay: - Required Skills for a Manufacturing Associate IV: $31.25 - $40.87 Pay Range - Required Skills for a Manufacturing Associate V: $33.17 - $43.27 Pay Range - Additional Information: The base compensation range for this role is: $31.25-$43.27 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. We need to preserve all that. Benefits list: - 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 Schedule: - 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. - This role follows a 2-2-3 calendar rotation on nights (6:00 PM – 6:00 AM ET) - Internal Shift Details: Black Nights rotating schedule We should include that. Now produce HTML fragment. Make sure to use for each section heading. Use - for lists. Use
for prose.
We must not include any extra text like explanations.
Let's craft.
About the role paragraph: combine the description and Who You Are.
Paragraph: "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 nights (6:00 PM – 6:00 AM ET). Internal Shift Details: Black Nights rotating schedule. Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). This Role’s Primary Focus Is Downstream (Purification) Column Chrom
for prose. We must not include any extra text like explanations. Let's craft. About the role paragraph: combine the description and Who You Are. Paragraph: "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 nights (6:00 PM – 6:00 AM ET). Internal Shift Details: Black Nights rotating schedule. Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). This Role’s Primary Focus Is Downstream (Purification) Column Chrom