Css Scientific Jobs in Usa

• Manufacturing Job Type: Full-time
  
  

• 1st Shift: 7:00 am - 3:30 pm EST
• 2nd Shift: 3:00 pm - 11:30 pm EST Training: Must be available for training from 8:30 am - 5:00 pm EST for one month.
  
  

• Operate pharmaceutical production machinery, following procedures for manufacturing activities such as weighing, blending, dispensing, mixing, granulating, drying, compressing, and encapsulating.
• Adhere to SOPs to ensure material purity and proper equipment usage.
• Verify materials against Product ID Labels, QC release tags, and Batch Production Records.
• Clean and perform machine changeovers, conduct in-process product quality checks, and document results accurately.
• Follow assigned schedules and participate in debriefs to address any production issues.
  
  

• Maintain accurate documentation of manufacturing processes in batch records, logbooks, and protocols.
• Complete and attach verification tickets, updating status boards as needed.
  
  

• Assist in troubleshooting, participate in improvement projects, and address deviations with the supervisor.
  
  

• Comply with all cGMP, SOP, policy, and safety requirements.
• Participate in safety meetings and maintain a clean, organized work area.
  
  

• Fulfill all training requirements, including machine-specific training.
  
  

• Share knowledge with team members, contributing to the overall success of projects and initiatives.
  
  

• High school diploma, GED, or Associate Degree.
• 1-3 years of experience in a physically demanding environment.
• Proficiency in English (verbal and written).
  
  

• High school diploma, GED, or Associate Degree.
• 3-7 years of experience in OSD pharmaceutical manufacturing.
• Forklift certification may be required for specific roles.
  
  

• High school diploma, GED, or Associate Degree.
• 7+ years of pharmaceutical manufacturing experience, with relevant certification or demonstrated proficiency.
  
  

• Experience in solid dose manufacturing (OSD) and equipment operation.
• Proficiency in areas like Compression, Granulation, Encapsulation, Coating, etc.
• Familiarity with FDA regulations, GMP, Lean Manufacturing, and Six Sigma principles.
• Basic math, reading, and problem-solving skills.
• Ability to participate in Continuous Improvement projects.
  
  

• Ability to stand for extended periods, lift at least 50 pounds, climb ladders, wear a respirator, and all required PPE (safety glasses, earplugs, safety shoes).
  
  

Join a team that’s shaping the future of biopharmaceutical manufacturing!

At ABEC, we don’t just build equipment—we enable life-saving therapies to reach patients faster and more efficiently. As a global leader in bioprocess solutions, we combine decades of experience with cutting-edge engineering to help our customers reduce costs, accelerate time to market, and maximize productivity.

Why ABEC?

• Day 1 Benefits: Medical, dental, and vision coverage starts immediately.
• Generous 401(k): 40% company match.
• Paid Time Off: Holidays and vacation to recharge.
• Company-Paid Life Insurance
• Education Support: College tuition benefit program.
• Employee Referral Bonus Program

Your Impact

As Manufacturing Manager, you’ll be at the heart of our operations—leading a talented team to deliver high-quality products on time, every time. You’ll drive efficiency, champion continuous improvement, and create a safe, collaborative environment where people thrive.

What You’ll Do

• Lead and optimize manufacturing output—adjust staffing and resources to keep projects on track.
• Foster a culture of continuous improvement using lean principles and data-driven decisions.
• Partner with Quality Control to maintain top-tier standards and resolve issues quickly.
• Develop and mentor future leaders within your team.
• Ensure safety compliance and investigate incidents promptly.
• Collaborate across departments to solve challenges and meet customer expectations.
• Set strategic goals and execute plans that boost productivity and profitability.

What We’re Looking For

• Bachelor’s degree in Engineering (preferred).
• 3–5 years of supervisory experience in manufacturing.
• Strong understanding of capacity planning and lean manufacturing.
• Ability to read engineering drawings and lead technical teams.
• Excellent communication, organizational, and leadership skills.
• Prior experience with Lean, Six Sigma, or CI is a plus.
• Physical ability to stand, walk, and lift up to 50 lbs.

Ready to make an impact? Apply today and help us deliver solutions that matter.

BioTalent is partnering with a leading life sciences manufacturer to appoint an Associate Director, Lean Deployment, to lead and elevate the organisation’s Continuous Improvement strategy across its New Castle, Delaware operations.

This is a high-impact role responsible for driving a culture of sustainable change by developing, embedding, and championing Lean and Continuous Improvement methodologies. The successful candidate will collaborate closely with site leadership and a global continuous improvement peer network to improve manufacturing and back-office processes while shaping long-term Lean strategy and deployment.

Key Responsibilities

• Partner with site leadership to develop and execute a site-wide Continuous Improvement roadmap within the organisation’s Lean Operating System.
• Lead transformation initiatives across critical operational areas.
• Facilitate Structured Problem Solving and Value Stream Mapping to guide teams through analysis, planning, and implementation.
• Build and enhance tiered visual and daily management systems that enable effective operational oversight.
• Plan and facilitate kaizen events that drive measurable, sustainable improvements.
• Identify and eliminate waste across transactional and manufacturing processes to increase efficiency and reduce cost.
• Deliver both formal and informal training on Lean and CI tools including Daily Management, Problem Solving, 6S, SMED, Kanban, OEE, and line efficiency.
• Coach and develop employees at all levels to expand Lean capability and CI mindsets.
• Challenge existing processes to elevate performance and drive continuous, sustainable improvement.
• Support improvements across other sites or functions as needed.

Qualifications

• 10+ years of progressive experience in a manufacturing environment.
• Bachelor’s degree required; advanced degree preferred.
• Proven ability to engage leaders and shop-floor teams in Lean deployment.
• Demonstrated history of delivering sustainable results through CI initiatives.
• Practical experience in Lean Manufacturing and the deployment of a Lean Operating System.
• Strong knowledge of value stream improvement tools (e.g., SMED, 6S, Visual Management, Daily Management, standard work).
• Lean/Six Sigma Black Belt certification or equivalent preferred.
• Strong leadership presence with the ability to influence at all levels.
• Proficiency in advanced statistical and Six Sigma techniques is an advantage.
• PMP certification or similar project management credentials preferred.
• Skilled in Microsoft Office and Visio.
• Excellent communication, facilitation, coaching, and problem-solving skills.

Reach out to for more information.

Job description:

Position Description: Living Ink Technologies ( ) is an innovative biomaterials company displacing the use of petroleum pigments by using biological sources as colorants for printing ink products. The company produces sustainable pigments, packaging, publication and screen inks. Living Ink is starting to produce product for some of the largest brands in the world that include Nike, Adidas, Patagonia, Marmot, Coach and others.

This position is best suited for individuals interested in production of algae pigments and inks in order to fulfill customer orders. The position requires active and engaged lifting, moving and mixing of raw materials for the production of large batches of finished pigments, and inks. This opportunity will provide the ability to work within a collaborative environment while also gaining startup industry experience at the intersection of innovation/product development/production. Competitive applicants must demonstrate a high level of independent work and exhibit strong problem-solving abilities. Significant opportunities to grow skill-sets, professional development and move up within the company.

● Location: Berthoud, CO

● Employment Status: Salaried, Full-time, Exempt

● Experience Level: 2+ years of production experience

● Compensation and Benefits: Salary dependent upon experience; health insurance, workers comp insurance, flexible schedule

● Desired Start Date: April 1st, 2026, preferred

Position Expectations:

Production (100%)

● Maintains and operates dedicated ink and pigment manufacturing equipment (mills, filter press, mixers, etc.)

● Fulfills scheduled production orders for finished good ink and pigment product lines

● Preforms quality control procedures for finished good ink and pigment products in accordance with established QA/QC standards

● Works with shipping/receiving department on inventory tracking initiatives

● Works on cross-departmental initiatives on behalf of R&D, engineering, and manufacturing

● Fulfill tasks as defined by production and facilities supervisors

● Capability to lift 25lbs-50lbs regularly

● Willingness to wear safety equipment (air respirator, safety glasses, hearing protection, steel toed boots) for sustained periods during the work day

Personal Qualifications: Hard-working and motivated. Enjoys learning, being challenged and problem solving. Strong organizational and record-keeping skills. Detailed oriented.

Equal Employment Opportunity: Living Ink provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job Types: Full-time, Part-time

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Work Location: In person

Title: Manufacturing Tech - Cell Therapy

Duration: 1 year contract

Location: Berkeley, CA

POSITION SUMMARY-

Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.

• Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Differentiation, Filling, Visual Inspection, Solution Preparation and Weigh/Dispense.

• Cell Culture Maintenance: Prepare and maintain cell culture environments, including media prep, cell counting, and growth monitoring.
• Quality Control: Perform quality checks, following strict protocols for contamination prevention.
• Data Recording: Accurately record data on cell growth and production metrics to ensure reliability.
• Collaboration: Work with Quality Assurance and Production teams to meet production targets

Skillsets:

• Manufacturing Experience: Hands-on experience working on a manufacturing floor ideally with exposure to downstream development processes.
• GMP and GDP: Experience with GMP processes, familiarity with SAP, and capability to handle 12-hour shifts
• Documentation: Experience with Batch Production Records (BPRs), SOPs, and log books, including:
• Experience with Batch Production Records (BPRs), SOPs, and log books.
• Ensure candidates know that if procedures aren’t followed, they are required to initiate and document deviations according to GDP standards.
• Experience preparing labels, filling out documentation, and reviewing logbooks accurately in a GDP-compliant manner.

Work Schedule

• Regular Hours: 9 a.m. to 5 p.m.
• Flexibility: Two weeks before each scheduled surgery, shift times may change to ensure timely delivery to the hospital. Flexibility to adjust hours within a 40-hour week is required.

Environment:

• Class B Workspace: All activities occur in a Class B space with a Biological Safety Cabinet (BSC).
• Environmental Monitoring: Includes testing and monitoring on equipment.
• Use of LM2 Freezers: Liquid nitrogen freezers are required for freezing products prior to shipping.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

Portsmouth, NH

12-month contract, potential for extension or conversion

Nights - 7PM - 7AM

The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.

• Attain qualification for all assigned tasks and maintain individual training plan.

• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.

• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.

• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a "clean room" environment.

Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects.

• Perform other duties as assigned.

Job Purpose

Responsible for the execution of all aspects of solid-dosage manufacturing which includes, but is not limited to, the dispensing, granulation, sifting, milling, drying, encapsulation, coating, compression, and cleaning related activities. Must be able to interact daily with all site support personnel as required. Must be able to complete all required batch record documentation in a thorough, accurate, and legible manner in English. Must be capable of reading and understanding all documented Standard Operating Procedures in English plus demonstrate competency through action and written evaluation.

Essential Duties and Responsibilities include the following. Other duties may be assigned:

• Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations.
• Participate in all Quality Investigations as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the cGMP area is cleaned and maintained following all SOP’s and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

To perform this job successfully, an individual should have:

• Familiarity with working in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Excellent written communication skills.
• Familiarity with various cGMP solid dosage Pharmaceutical manufacturing equipment. Able to setup, operate clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
• Able to work with minimal supervision.
• Able to stand on feet throughout an eight-hour work day.
• Able to lift up to 30 Ibs (14 Kgs) without assistance.
• Maintain personal hygiene habits consistent with working in a cGMP environment
• Be capable of wearing all required PPE; including partial and full facepieces based on OSHA guidelines.

Education :

High School Diploma or GED Equivalent.

Bachelor’s degree in Physical Sciences or Pharmaceutical life science related field of study.

Years of related experience

2-8 years related experience in cGMP production operation activities.

Must have Valid work permit.

Kelly® Science & Clinical is seeking several Biomanufacturing Associates for Direct Hire positions at a premier biotech company in the Portland, OR area. If you're motivated, detail-oriented, and eager to contribute to a fast-paced manufacturing environment, this is a great opportunity to take your career to the next step!

Pay Rate:

2A: Base pay $21/hour + shift differential = $26.12/hour

2B: Base pay $21 + shift differential = $25.86/hour

Schedule:

2A: Alt Sat, Sun-Tues, 7:00pm-7:30am OR

2B: Alt Sat, Weds-Fri, 7:00pm-7:30am

Overview:

As a Biomanufacturing Associate, you will play a vital role in producing high-quality, custom oligonucleotide products that power the future of biotech. In a dynamic and fast-paced lab environment, the role involves adhering to SOPs, operating automated lab equipment, documenting processes, and supporting manufacturing schedules, with a strong focus on quality and safety practices.

Company Culture

Fast paced environment without too much structure/red tape to make decisions. Growth opportunities available within a 110K sq ft state-of-the-art “factory of the future” that was completed and started production in 2022-2023.

Responsibilities:

• Contribute to the production of high-quality custom products in a high-throughput lab, following established SOPs and manufacturing standards.
• Efficiently perform molecular and cell biology processes, including PCR and DNA purification, contributing to the production of custom DNA-based products.
• Independently handle the operation of various laboratory equipment and robots while ensuring safety and adherence to ISO and lean manufacturing practices.
• Thoroughly document processes and update work instructions, supporting troubleshooting and maintaining high attention to detail.
• Organize shipping of products and maintain consistent work output under minimal supervision.

Qualifications:

• Bachelor’s degree in Biology, Biochemistry or related field OR previous experience working in GMP environment.
• Fresh graduates or candidates with relevant laboratory experience in a manufacturing or high-throughput biotech setting will be considered
• Familiarity with molecular biology techniques such as PCR, DNA quantitation / purification
• Strong documentation skills with attention to detail
• Ability to work independently, follow SOPs precisely, and work safely with chemicals and hazardous materials
• Good computer skills, including proficiency with Excel and Word
• Comfortable working in a team-oriented laboratory environment and standing for extended periods
• Ability to work on the night shift

Seize the opportunity to be part of something extraordinary where your work contributes to revolutionary advances in health, sustainability, and technology. Apply now and help us write the future of DNA synthesis!

Manufacturing Technician - San Antonio

Position Summary:

The Manufacturing Technician is responsible for performing human tissue processing activities in accordance with FDA regulations, AATB Standards and SOPs.

Essential Functions:

• Prepares sections of human tissue for surgical implantation
• Utilizes special techniques, instrumentation, and equipment to evaluate, cut, shape, grind and package tissue to exacting specifications and protocols
• Accurately completes paperwork and perform data entry when applicable
• Performs Lab Support functions of the set-up and breakdown of rooms and handling of donor tissue (passing in) using aseptic technique and maintaining sterile fields
• Maintains supplies and equipment on a daily basis
• Understands and properly handling the disposal of Biohazardous and Non-Biohazardous waste
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
• Self-starter
• Advanced critical thinking and problems-solving skills
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:

• High school diploma/GED preferred or at least one year of related experience
• 1 year of manufacturing experience; preferably working in an aseptic/sterile environment and/or Tissue Processing or operating room
• Experience with the use of precision measuring equipment such as calipers and micrometers
• Experience operating electrical and pneumatic cutting, drilling, and routing equipment
• Excellent organizational and verbal/written communication skills with the ability to understand and communicate (speak, read & write) in English
• Must have basic computer knowledge skills
• Demonstrated organization skills and attention to detail