Upstream Bioprocessing Jobs in Usa

Rangam is seeking candidates for a Direct Hire role as a Sr. Associate Scientist, Upstream Process Development with our client, one of the world’s largest pharmaceutical companies.

Seeking candidates in Andover, MA or willing to relocate.

Why Patients Need You

Client's purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling client's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or developing manufacturing processes in support of clinical studies, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.

What You Will Achieve

A Senior Associate Scientist (R2) position is available in the Upstream Process Development group within the Bioprocess R&D organization. The successful applicant will join a team of scientists and engineers focused on developing and optimizing manufacturing processes for recombinant proteins and other modalities for early- and late-phase human clinical trials. In this role, the candidate will be responsible for designing and executing laboratory experiments in bench-top bioreactors and associated scale-down equipment with the goal of developing robust, scalable, and high productivity processes. The work will also involve working with pilot, clinical, and commercial production facilities to ensure accurate technology transfer, successful large-scale production and associated regulatory filing activities. The candidate may also be involved in cutting edge technology development projects that seek to improve production processes and control strategies leveraging various process analytical technologies.

How You Will Achieve It

• Design and execute experiments in appropriate scale-down models such as shake flasks and bioreactors in an effort to develop robust, high yield, and scalable manufacturing processes
• Serve as upstream tech lead; ensure accurate tech transfer to pilot and GMP manufacturing facilities; provide technical support during manufacturing campaign
• Timely and accurately document data in electronic lab notebooks; author technical reports and contribute to relevant sections of regulatory submissions such as IND and BLA
• Participate and contribute to discussions in lab and project team meetings on design of experiments and interpretation of data
• Contribute to safe, efficient, and harmonious lab environment; strong lab citizen and collaborative team player
• Occasionally work over the weekend to passage flasks, sample bioreactors or perform other essential tasks

Qualifications

Must-Have

• Bachelor’s degree with 3-5 years’ industrial experience or Master’s degree with 0-3 years industrial experience in Chemical/Biochemical Engineering, Biotechnology, Microbiology or a relevant field.
• Significant experience with sophisticated lab instruments such as bioreactor systems and analytical equipment.
• Strong mammalian cell culture expertise required.
• Self-motivated, organized, and excellent attention to details.
• Excellent oral and written communication skills.
• Ability to adapt in a fast-paced environment with shifting priorities.

Nice-To-Have

• Experience with high-throughput instrument such as ambr15, ambr250, and Tecan liquid handler
• Experience with developing and implementing process analytical technologies such as Raman spectroscopy and biocapacitance.
• Proficiency with multi-variate data analysis techniques

PHYSICAL/MENTAL REQUIREMENTS

Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May require occasional work on the weekend for essential tasks and may need to travel occasionally to attend internal meetings or external conferences.

Work Location Assignment: On Premise

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in client's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with client's Matching Contributions and an additional client's Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at client's Candidate Site – U.S. Benefits | ( ** ). Compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

To find out more about Rangam, and this role, click the apply button.

Satnam Singh

SA Technical Recruiter | Rangam Consultants, Inc

M: (513) 447-8917

E: | W: [

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

In this key role on the High Purity Sales Team, the Territory Manager is a sales professional responsible for managing and growing sales within a designated geographic area by building customer relationships, identifying new business opportunities, executing sales strategies and meting sales targets, handles product strategy, technical product management and sales. The BPM is the face of HPNE to the customer. This position must understand and then represent the client and the product requirements. The Territory Manager will work with the engineering, client services, materials, quality and production teams to ensure the product requirements and workflow are accurate. The Territory Manager is responsible for the overall customer satisfaction and retention.

Key Duties and Responsibilities:
The responsibilities include but are not limited to:

• 
  
• Identify new business opportunities aligned with the organization's growth strategy
  
• Actively drive HPNE product portfolio and services into the marketplace and defined region
  
• Maintain customers and build long-term relationships
  
• Meeting and exceeding sales targets
  
• Ensure efficiency with sales team and operations
  
• Present products and services to prospective customers
  
• Analyze data to find the most effective sales methods
  
• Provide technical support to customers for upstream and downstream processes
  
• Participating in industry events and trade shows
  
• Conduct onsite demonstrations
  
• Maintain updated and accurate account information
  
• Maintain strong cross functional relationship with key stakeholders in other departments
  
• Monitor competition within assigned region
  
• Stay abreast industry developments and customer announcements
  

Required Skills and Abilities:

• 
  
• Familiarity with Salesforce is a plus
  
• Ability to prioritize and multitask
  
• Proven sales skills
  
• Excellent written, verbal and presentation communication skills
  
• Strong attention to detail
  
• Ability to work effectively on a cross functional team and independently
  

Education and Experience:

• 
  
• Bachelor's degree in a science or technical major area preferred
  
• 5 years of sales experience required, ideally in biotech, bioprocessing or life science sector
  
• Proficient in MS office
  

#LI-MV1

The total compensation range (base plus at plan target incentive/commission) is between $195,000-210,000 per year with a six month guarantee depending on experience and location

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Title: Bioprocess Technician

Location: Berkeley, CA

Duration: 6 month contract, potential for FTE conversion

Required Skills & Experience

• 0-2 years of experience
• Aseptic qualifications or training (media fill, gowning certification)
• Buffer Prep
• Experience in drug product filling, visual inspection, or pharmaceutical compounding
• Strong understanding of GMP compliance
• Background in manufacturing processes such as silicon chip production or similar regulated environments

Job Description

We are seeking a highly motivated Bioprocess Technician. This role is critical in supporting aseptic operations and ensuring compliance with GMP standards for drug product filling and related processes. The ideal candidate will have hands-on experience in aseptic techniques, drug product filling, and GMP environments.

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.

Position Summary:

The Associate Director, Quality Control will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bio’s lead program verekitug. This role will manage and execute GMP quality control (QC) activities directly related to batch release for clinical trial material supply. The leader in this role must assure that quality controls for investigational new drugs (investigational medicinal products) meet all quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations. The Associate Director will report to Senior Director of Analytical and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch.

Key Responsibilities:

• Author, review and approve analytical method procedures/SOPs
• Author, review and approve analytical method transfer/qualification/validation protocols and reports
• Manage external CDMOs and CROs to execute Development and GMP release and stability testing of Drug Substance and Drug Product in a compliant-manner
• Establish and manage reference standard and critical reagent programs
• Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review.
• Perform data verification and audits in order to ensure accuracy of data and analytical processes.
• Ensure compliance with company policies and SOPs as well as global health authority guidelines.
• Create, analyze, verify, and approve QC data such as method validation, release and stability, results, reports, and Certificates of Analysis (COAs).
• Generate, review, and revise specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.

Qualifications:

• Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
• Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
• Proficiency with Microsoft software (Word / EXCEL / PowerPoint), Stability software and statistical analysis/trending to support shelf life and labeling is expected.

Knowledge and skills (general and technical) preferred:

• Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification.

Education level and/or relevant experience required:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of demonstrated success in leading cross-functional teams and managing projects along with 7+ years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. Any ASQ or other certifications is a plus.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $176,400 - $215,600

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Position Summary:

We are seeking a highly motivated attorney to join our legal team as Corporate Counsel/Sr. Corporate Counsel. This role will support the company’s public company reporting obligations, corporate governance processes, compliance initiatives, and contracting activities across the organization. Title and level will be determined based on experience and scope of responsibility.

This position is well-suited for a life sciences attorney who thrives in a fast-paced, clinical-stage biotech environment and enjoys partnering with cross-functional teams to provide practical legal guidance. The role requires strong attention to detail, sound judgment, and the ability to manage a broad range of legal matters in a growing organization.

The successful candidate will work closely with the General Counsel and senior leadership, partnering with teams across Finance, Investor Relations, Clinical Development, Regulatory, Technical Operations, and HR, and coordinating with external counsel as needed.

Key Responsibilities:

Securities & Corporate Governance

• Assist in the preparation and review of SEC filings, including Forms 10-K, 10-Q, 8-K, proxy statements, and Section 16 filings.
• Partner with Finance and Investor Relations to support the company’s disclosure processes, planning and drafting, including for earnings releases, investor presentations, and proxy materials.
• Monitor and advise on securities law compliance, including Nasdaq listing standards, Sarbanes-Oxley requirements, and insider trading policies.
• Provide legal support for capital markets transactions, including equity offerings and financings common in clinical-stage biotech companies.
• Support Board of Directors and committee governance activities, including preparation of board materials and maintenance of governance documentation.
• Provide legal guidance on corporate governance and regulatory requirements affecting the organization.
• Partner with HR and leadership on matters including equity plans and corporate policies.

Healthcare, Data Privacy, and Corporate Compliance

• Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies, establishing the Compliance function as an approachable, knowledgeable, practical, and solutions-oriented business partner.
• Assist with the development and maintenance of policies and procedures to support the company’s corporate governance initiatives, healthcare compliance programs, and privacy framework, including the company’s code of business conduct and ethics.
• Serve as the go-to internal lead for guidance concerning compliance-related regulations, including data protection, information security, GDPR, and HIPAA, and monitor changes in healthcare compliance and data protection requirements to operationalize “fit for purpose” program updates.
• Coordinate and support the company’s privacy program activities, including Data Protection Impact Assessments (DPIAs), Records of Processing Activities (RoPAs), data mapping, maintenance of related documentation, and facilitation of data subject requests.
• Lead risk assessments to identify and prioritize compliance-related risks.
• Develop and deliver risk-based compliance training and guidance materials for employees across the company.
• Partner with the company’s Information Technology team to mitigate information security-related risks, including risks related to AI adoption, privacy matters, and cybersecurity incidents.

Contracting Matters

• Draft, review, and negotiate a wide range of life sciences agreements, including:
• Clinical trial agreements
• CRO and vendor agreements
• Manufacturing and supply agreements
• Licensing and collaboration agreements
• Research and development agreements
• Technology and services agreements
• Serve as a legal partner to cross-functional teams including Clinical Development, Regulatory, Technical Operations, R&D, and G&A functions.
• Support negotiation of complex and high-impact agreements, liaise with our clinical research organizations (CROs) to manage all aspects of contracting processes for large scale clinical trials, and escalate strategic matters as appropriate.
• Contribute to the development of contract templates, playbooks, and contracting best practices to improve efficiency and consistency.

Cross-Functional Legal Support

• Partner with the General Counsel and legal team on a variety of matters affecting the organization.
• Provide legal support on issues arising throughout the drug development lifecycle, including regulatory, operational, and compliance considerations.
• Coordinate with external counsel and internal stakeholders to support key legal initiatives and transactions.
• Contribute to a collaborative, business-oriented legal function that supports the company’s mission and growth.

Qualifications:

• J.D. from an accredited law school and admission to practice in at least one U.S. jurisdiction.
• 6+ years of legal experience, including corporate securities, compliance, and/or commercial contracting experience at a top law firm and/or public life sciences company.
• Strong knowledge of SEC regulations, Sarbanes-Oxley, public company disclosure requirements, and stock exchange listing standards.
• Experience drafting and negotiating complex life sciences or other agreements, particularly those supporting clinical development and technical operations.
• Understanding of drug development lifecycle and regulatory environment impacting biotechnology companies.
• Excellent analytical, communication, and stakeholder management skills.
• Ability to manage multiple priorities, make decisions with incomplete information, and operate effectively in a fast-paced, collaborative environment.

Preferred Experience:

• Experience supporting a clinical-stage biotechnology or pharmaceutical company.
• Familiarity with clinical development operations, CRO agreements, manufacturing agreements, and licensing transactions.
• Experience supporting public company reporting and governance processes.
• Experience working in a lean legal team environment with exposure to a broad range of legal matters.
• Demonstrated project management skills, including successful execution of complex projects with multiple stakeholders and utilization of soft skills to maximize team collaboration and effectiveness.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at .

Compensation

Target Salary Range: $234,000 -$286,000

*Base Compensation for this role will depend on a number of factors including a candidate’s qualifications, skills, competencies, and experience. Base pay is only one component of the company’s total rewards package. All regular employees are also eligible for the company’s cash bonus and equity incentive programs. Additional benefits include health care, vision, dental, retirement, PTO, etc.

• 
  
• You will join a team of seven scientists responsible for producing pilot-scale biological products that support biologics programs, trouble shooting and improving processes. The team implements new technologies to enhance operational capability, capacity, and efficiency across the site.
  

• 
  
• Technical & Operational
  
• Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
  
• Support upstream operations as needed to ensure seamless end-to-end process execution.
  
• Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
  
• Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.
  
• Communication & Collaboration
  
• Present data, results, and conclusions in group meetings and cross functional discussions.
  
• Communicate technical information clearly and effectively to colleagues at varying levels.
  
• Work with a team-oriented, collaborative, and solutions-focused mindset.
  
• Maintain a strong safety focus in all laboratories and pilot operations.
  

• 
  
• Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
  
• Proficiency with AKTA systems and UNICORN programming.
  
• Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
  
• Strong verbal communication, technical writing, and documentation skills.
  
• Ability to work effectively in cross functional teams and in a dynamic environment.
  
• Self-motivated, organized, and comfortable with scientific problem solving.---
  

• 
  
• Experience in pilot plant operations for biologics in a single-use facility.
  
• Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles.
  

• 
  
• AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
  
• BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.
  

• 
  
• Initial Zoom screening, followed by 1:1 interview with the hiring manager and 1-2 team members.
  

• 
  
• Onsite
  

Location: On-site in Upstate NY (Relocation from Canada welcome!)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Full-Time | Onsite

About the Role:

We are seeking a detail-oriented and technically proficient Process Engineer who will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

Responsibilities

• Work with Upstream equipment
• Fermentation
• Process optimization
• Process scale-up or scale-down studies
• Commissioning and Qualification
• Protocol generation and execution
• Data analysis
• Report writing
• Author SOPs
• Great communication skills (presenting, and writing)
• Protein expression/purification
• GxP (GDP, GLP, or GMP a major asset)

Minimum Requirements

• Bachelor’s or master’s degree in Biochemistry, Biology, Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.
• Required: 3+ years of experience in the biotech-pharmaceutical academic or industrial environment.
• Bioprocess experience preferred
• Fill finish experience preferred
• Basic knowledge of upstream/downstream drug substance manufacturing.
• Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
• Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
• Demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment.
• Basic knowledge of the Commissioning and Qualification.
• Travel within USA as needed for the projects.

Perks & Benefits:

• Competitive salary
• Full health, dental, vision, and retirement benefits
• Tuition reimbursement, PTO, and more

MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)

Location – Wilson, NC

Aztec Technologies is an engineering and consulting firm providing expertise in the

pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation

are part of Trinity Consultants Company.

Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting

services with 1500+ engineers worldwide.

Aztec Technologies provides solutions for Manufacturing Applications:

• Process and Facility Automation

• Project Management

• MES

• Data Analytics

With offices across 3 continents, consulting firm with over 20 years of experience within the

biopharmaceutical and pharmaceuticals industries.

The successful candidate will work with a group of engineers involved in the design, automation,

commissioning and start-up of various processes, systems, and facilities. A combination of

strong technical aptitude, automation engineering skills and technical writing are the desired skill

set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences

space that will enhance professional opportunities!

Candidates need to be local or willing to relocate to the areas of operation where we have open

opportunities for immediate hire in the Wilson, NC area:

Key Responsibilities:

• Own MES configuration management for PAS-X, including:
• Manufacturing Batch Records (MBRs)
• Material management
• Equipment and timer management
• Label management
• Lead MES design, configuration, testing, and troubleshooting
• Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
• Support MBR migration from a legacy site
• Ensure alignment with site and global MES standards
• Support risk assessments and GMP compliance activities
• Provide hands-on troubleshooting and technical support during execution
• Develop and maintain MES technical documentation
• Collaborate closely with IT, Manufacturing, Quality, and Engineering teams

Required Qualifications

• 8+ years experience in pharmaceutical or biopharmaceutical manufacturing environments
• Strong hands-on experience with MES platforms, preferably Werum PAS-X
• Proven experience with MBR design and execution
• Solid understanding of GMP manufacturing processes
• Experience integrating MES with DCS (DeltaV) and enterprise systems
• Strong analytical, troubleshooting, and problem-solving skills
• Bachelor’s degree in Engineering, IT, Science, or related discipline

Preferred / Nice-to-Have Skills

• Programming experience: .NET, SQL / PL-SQL, Java
• Experience with OPC servers/clients
• Knowledge of 21 CFR Part 11 and EU GMP Annex 11
• Process knowledge across:
• Upstream
• Downstream
• Bioprocess support functions
• Ability to communicate effectively with both technical and non-technical stakeholders

Ideal Candidate Profile:

• Senior-level PAS-X MES SME
• Strong on-site presence and ownership mindset
• Comfortable operating as Owner’s Rep, not a junior configurator
• Deep pharma/biotech automation background
• Able to bridge Manufacturing, IT, Automation, and Quality