Manufacturing Downstream Associate I/II
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to include sections only when posting has real specific content. We have:
- Description: company overview, mission. Could be "About the role" maybe "About the company". But they said "About the role" as example. We'll use "About the role" for the description paragraph.
- Responsibilities: "Essential Duties & Responsibilities" list.
- Requirements: "Minimum Qualifications" and "Preferred Qualifications". Could combine into Requirements section.
- Benefits: list of benefits/perks.
- Pay: compensation details.
- Schedule: shift info.
We must not repeat job title as heading. No Job ID etc.
We must preserve all substantive info, not invent.
We must not include boilerplate like EEO etc. Remove that.
We must not include application instructions.
We must not include duplicated lines.
We must not include sections with filler like "N/A". We have Supervisory Responsibility N/A - we should omit that line.
We need to output only HTML fragment, no /, no markdown fences.
We'll produce something like:
About the role
Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
Responsibilities
- Demonstrate a sound knowledge and understanding of cGMP requirements.
- Adhere to real-time documentation during production run and maintain accurate records/logs.
- Setup, operate, and break down downstream equipment including chromatography columns, controllers, and TFF systems.
- Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
- Perform calculations for processing, weighing materials, chemical and reagent additions.
- Use programs to collect and evaluate operating data to conduct online adjustments to products, instruments, or equipment.
- Work with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
- Follow all GMP instructions in the manufacturing area and take responsibility / ownership of environmental health and safety policies.
- Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
- Comply with all company policies and standards. Ensuring all operations comply with cGMP, safety, and data integrity standards.
- Performs other functions as required or assigned.
- Revision of solution preparation batch records, SOPs, Protocols and logbooks.
- Providing support during quality audits and regulatory inspections.
- Material & Inventory Management: Order, maintain, track, and staging of raw materials and consumables for upstream, downstream, and media/buffer preparation processes.
- Perform label verification, receipt checks, and electronic inventory updates.
- Coordinate with warehouse and planning teams for material readiness.
- Managing material inventory inside cleanroom areas.
Requirements
Minimum Qualifications: Education: High school diploma or equivalent required. Bachelor’s degree preferred. Experience in a manufacturing environment or 1-2 years of relevant experience preferred. Familiarity with safety protocols/procedures Ability to understand and adhere to written and verbal instructions. Excellent written and verbal communication skills. Ability to communicate technical details at all levels, including senior leadership Ability to work well with a wide range of people from other groups in a team-oriented environment with cross-functional groups. Ability to learn to properly use various hand and electrical tools. Ability to work in a fast-paced environment and handle changing manufacturing demands. Proficient in MS Word, Excel, and PowerPoint. Ability to troubleshoot technical issues and propose short- and long-term solutions. Strong time-management skills and the ability to work under demanding timelines. Work in a team environment and be able to work independently with minimum supervision. Ability to learn to properly use various hand and electrical tools.
Preferred Qualifications: The preferred candidate would have general working knowledge of AKTA purification skids or similar, tangential flow filtration (TFF), columns, and single-use consumable technologies such as bags, tube sets, columns, and process manifolds. Previous hands-on experience working with mammalian cell lines in a GMP and aseptic commercial manufacturing setting with biopharma or biotech. Proficiency in aseptic operations and in-process sampling.
Benefits
- Medical Insurance - Aetna
- Prescription Drug Converge | Rx
- Virtual Visits - Aetna/Teladoc
- Health Savings Accounts (HSA)
- Flexible Spending Accounts (FSA)
- Dental Insurance - Aetna
- Vision Insurance - VSP
- Life and AD&D Insurance
- Disability Benefits
- Supplemental Benefits
- Legal Services
- ID Theft Protection
- Travel Assistance
- Value Added Benefits & Services
- Health Advocate
- Life Assistance Program (LAP)
- Student Loan Assistance Program
- 401K
- Monthly Cell Phone Allowance
Pay
Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings. Manufacturing Associate I (0–2 years of biologics manufacturing experience): $30–$36 per hour with up to a 5% yearly cash bonus. Manufacturing Associate II (2–4 years of biologics manufacturing experience): $34–$38 per hour with up to a 5% yearly cash bonus. Kashiv BioSciences can provide sponsorship support for qualified candidates. Please let us know if you currently require sponsorship or may require sponsorship in the future.
Schedule
As a biologics/biosimilars company, our schedules are driven by process requirements. Manufacturing Operations is 12hr shifts for 24/7 coverage (2-2-3 work schedule), including holidays and weekends. Shift A (day shift): 7:00 AM to 7:00 PM EST and Shift B (night shift): 7:00 PM to 7:00 AM EST. Initial training may be performed on the day shift. Required Overtime (time-and-a-half pay), holidays, and weekends. During the interview process, please let us know whether you have a preference for the day shift, the night shift, or are open to both.
We must ensure we didn't include any boilerplate like EEO etc. We removed that. Check for duplication: The responsibilities list includes "Revision of solution preparation batch records, SOPs, Protocols and logbooks." and "Providing support during quality audits and regulatory inspections." Good. We kept all substantive info. Check for any leftover filler: "Ability to learn to properly use various hand and electrical tools." appears twice in Minimum Qualifications; we kept both but it's duplicate in source; we could deduplicate but not required. It's okay. We must not include "Supervisory Responsibility, if any: N/A". We omitted. Check for any mention of "Interviews and employment are conducted onsite at our Piscataway, NJ facility. Candidates should currently reside within a reasonable commuting distance or plan to relocate to the area." That's substantive info about location; we haven't included it. Should we include? It's location info, maybe could be part of About the role or a separate section like "Location". But the instruction only gave examples of headings; we could add a section like "Location" if we want, but not required. However we must preserve ALL substantive information. So we need to include that location info somewhere. Could add aunder About the role or a separate section "Location". Since we already have About the role paragraph, we can append that info there. Also there is "As a biologics/biosimilars company, our schedules are driven by process requirements." Already in schedule section; we included. Also there is "Required Overtime (time-and-a-half pay), holidays, and weekends." Already in schedule. Also there is "During the interview process, please let us know whether you have a preference for the day shift, the night shift, or are open to both." Already in schedule. Also there is "Interviews and employment are conducted onsite at our Piscataway, NJ facility. Candidates should currently reside within a reasonable commuting distance or plan to relocate to the area." We need to include. We could add a
Location
but not in examples; but we can still use for any section heading; the examples are not exhaustive. It's okay to add Location.
Alternatively we could incorporate into About the role paragraph.
Let's add a separate Location
with that info.
Also there is "Kashiv BioSciences can provide sponsorship support for qualified candidates. Please let us know if you currently require sponsorship or may require sponsorship in the future." Already in Pay section.
Now check for any other substantive info: "Revision of solution preparation batch records, SOPs, Protocols and logbooks." included.
"Providing support during quality audits and regulatory inspections." included.
"Material & Inventory Management Order, maintain, track, and staging of raw materials and consumables for upstream, downstream, and media/buffer preparation processes." included as a bullet.
"Perform label verification, receipt checks, and electronic inventory updates." included.
"Coordinate with warehouse and planning teams for material readiness." included.
"Managing material inventory inside cleanroom areas." included.
"Ability to work flexible hours as needed." from Work Environment & Physical Demands; we haven't included that. Also "Ability to work under pressure and meet deadlines." Also "General Work Environment Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated and temperature controlled." etc. Also "Occasional desk / computer work (reading, editing, writing documents) as required." etc. Also physical demands: "Potential for chemical odor and dust exists." etc. Also "Standing/Lifting Must be able to move around the facility to reach various equipment." etc. We need to include all substantive info. We missed the Work Environment & Physical Demands section. We should add a section maybe "Work Environment & Physical Demands". Use Work Environment & Physical Demands
and include those details as
or
- . Let's extract:
- Ability to work flexible hours as needed.
- Ability to work under pressure and meet deadlines.
- General Work Environment: Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated and temperature controlled.
- Occasional desk / computer work (reading, editing, writing documents) as required.
- Potential for chemical odor and dust exists.
- Standing/Lifting: Must be able to move around the facility to reach various equipment.
- Physical lifting and shifting required for pushing and pulling pre-made buffer containers.
- Must be able to lift at least 25 lbs. to lift weights onto scale for daily scale verification.
- Must be able to stand for long periods of time.
- Occasional