Microbiology Development Tech Job at MillenniumSoft Inc (El Paso)

Contamination Control Manager

At SRG, we are excited to be partnering with our client, a biologics Contract De...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry

Fulltime

Contamination Control Manager

At SRG, we are excited to be partnering with our client, a biologics Contract De...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry

Fulltime

Synthetic Biology Intern

Eligo is building a pioneering platform technology that enables us to engineer p...

Location

France , Paris

Salary:

Not provided

Eligo Bioscience

Expiration Date

Until further notice

Requirements

Engineering or Master's student in Molecular Biology, Microbiology, Synthetic Biology, or related fields from EU country
Proficient and comfortable speaking and writing in English with a multi-national team
Ability to communicate across disciplines
Excellent problem-solving skills and attention to detail
Hard working and passionate
Autonomy, initiative, adaptation, and team spirit
General tech-savviness and nerdiness

Job Responsibility

Design and engineer bacterial strains, therapeutic DNA circuits and phage genomes
Your contributions will have a direct, tangible impact on the cutting-edge products being developed at Eligo as they progress from the benchtop to the clinic

What we offer

A team that is passionate, creative, driven, and at the top of their game
A fast-paced, international, interdisciplinary, inspiring, and collaborative work environment
An opportunity to apply cutting-edge technologies to solve real-world problems
A truly unique and fantastic company culture
Office and lab easily accessible via public transit
Secure parking for bikes on site
Numerous options for lunch
the Parisian life!

Fulltime

Director, Process Development

Moderna is seeking a Director to lead upstream process development with a primar...

Location

United States , Norwood

Salary:

167000.00 - 300700.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

PhD in Chemical Engineering, Biochemical Engineering, Microbiology, Biotechnology, or related discipline (or MS/BS with significant relevant industry experience)
Significant industry experience (10+ years) leading E.coli or microbial process development programs with demonstrated impact on strain development, bioreactor process scale-up/scale-down, robustness, tech transfer, and manufacturing readiness
Subject matter expertise in strain engineering and fermentation optimization, including extensive firsthand experience with developing bacterial expression/production processes for enzymes/plasmids
Deep expertise in E. coli fermentation, including high-cell-density fed-batch development and execution
Demonstrated strength in media and feed design and control of nutrient/trace element strategies
Strong understanding of fermentation physiology and practical understanding of microbial metabolism as it relates to process performance
Experience implementing and interpreting online/inline measurements including off-gas analytics and practical interpretation of OUR/CER for process state and control
Proven people leadership and ability to lead through ambiguity and fast timelines
Strong cross-functional influence and communication skills
ability to operate as a technical decision-maker and escalation point

Job Responsibility

Set strategy and lead execution
Own the host strain, expression vector/plasmid and upstream process development strategy for E. coli-expressed enzymes and plasmids
Translate needs into platform process roadmaps (speed, robustness, cost, scalability, quality attributes) and ensure predictable delivery from strain development through tech transfer of process
Build and develop a high-performing team
establish clear technical standards, decision rights, and development pathways for scientists and engineers
Drive best-in-class E.coli fermentation development
Lead upstream development for high-cell-density microbial fermentation (especially E. coli fed-batch) including media and feed design and development (defined/semi-defined media, carbon/nitrogen strategies, trace elements, antifoam, osmolality management)
Develop and optimize fed-batch strategies (substrate-limited feeding, exponential feeds, DO-stat / pH-stat strategies where appropriate, induction timing/intensity)
Optimize key process parameters (temperature shifts, pH, DO, agitation/aeration, backpressure, antifoam, bolus vs continuous feeding)
Apply DOE and data-driven development to define robust operating spaces, reduce variability, and improve titer, yield, and product quality

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Annual discretionary bonus
Other incentive compensation
Equity award

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality
Manages the Quality organization in a mid to large size plant
Manages the batch review and release activities
Fulfills the role of PRRC
Directs large programs and departments in support of division or company-wide initiatives
Develops and deploys the quality systems
Understands and deploys processes to assure conformance to regulations
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Scientific and Regulatory Affairs Expert

Bactolife is looking for an experienced scientific and regulatory affairs expert...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Collaborative team player with a proven ability to build and maintain strong, long-lasting relationships
Result- and solution-oriented, with a genuine interest in supporting business development
10+ years’ experience within Regulatory Affairs or related areas, preferably with vast experience from the food tech and/or consumer health space
Experience with precision-fermented/GMM-derived ingredients dossier preparation and approval
Good understanding of Novel Food regulations in EU and/or in the Asia-Pacific region
Excellent communication skills and the ability to connect with external stakeholders such as expert consultants, customers and authorities
Good project management skills and attention to detail
MSc or PhD in a relevant field, Biotechnology, Biology, Chemistry, Microbiology, Nutrition or other related scientific disciplines

Job Responsibility

Identify and work with expert consultants from the Asia-Pacific region
Prepare food ingredient dossier submission, registration, and renewal strategies for products within the region to gain and maintain market access
Support local consultants in engaging with key external stakeholders and local authorities in pre- and post-submission meetings
Understand and guide health claim options and substantiation hereof for different consumer product categories such as health/dietary supplements
Conduct compliance reviews and provide daily support to the business development team in preparing and executing customer pitches and dialogues
Support the regulatory tasks/questions to EU novel food approvals, our business development as well as our clinical research activities

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Fsqa Micro Technician

Under the direction of the Food Safety & Quality Assurance (FSQA) Manager or Sup...

Location

United States , Carthage

Salary:

Not provided

Ajinomoto Foods North America, Inc.

Expiration Date

Until further notice

Requirements

A High School Diploma or its equivalent is desirable
Meaningful education and experience may be substituted for the degree requirement
Sufficiently broad experience in food manufacturing Food Safety and Quality Assurance and/or food plant production operations, processes, and policies to permit execution of assigned duties is strongly desired
Limited food manufacturing experience combined with an appropriate college degree may be considered
Certifications such as HACCP, PCQI, or SQF are helpful
Must have keen ability to analyze problems encountered and to make reasonable decisions based on facts/data, procedures specifications and experience
Fluency in English (reading, writing, and verbal) is required
Good organizational, mathematical, and recordkeeping skills
Ability to conscientiously monitor aspects of incoming materials, product production, storage and distribution operations, and ensure that established material specifications, product production, product quality controls and sanitary standards are met
Computer literacy, word processing, and data entry skills are desired

Job Responsibility

Performs microbiological tests as required
Prepares and maintains necessary records and reports
Collects environmental, ingredient and finished product samples for bacteriological testing
Maintains a current and comprehensive knowledge of microbiological testing and analysis procedures
Conducts or assists with raw material/ingredient hazard analysis and risk assessments
May inspect equipment and facilities for cleaning deficiencies and other food safety issues
Will participate on the positive swab investigative team as the leader, investigator or swab tech
Assists in the training or instruction of laboratory personnel
Responsible for the proper maintenance and operation of all bacteriological equipment, Good Laboratory Practices (GLPs) and maintaining laboratory in a clean, sanitary and unadulterated state
Responsible for updating and maintaining the laboratory manual

Fulltime

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Microbiology Development Tech

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