Senior Microbiology/ Project Manager Job at Campden BRI (Chipping Campden)

Senior Project Manager, Research & Development

The hiring organisation is a pioneering Danish biotech company at the forefront ...

Location

Denmark

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Minimum of 5 years of practical project management experience from a biotech or pharmaceutical company, ideally in an R&D environment
Strong scientific background and hands-on understanding of microbiology and bacteriology
Documented experience leading complex, agile projects with a high degree of uncertainty
Ability to operate in cutting-edge research where outcomes are not always predictable and project plans must evolve quickly
Natural authority, professional weight and interpersonal maturity to gain respect from senior specialists
Strong listening skills combined with the ability to stand firm when project progress requires decisions, prioritisation or escalation
Ability to translate technical complexity into practical project actions and create alignment across different scientific and operational groups
A diplomatic and constructive style, with the ability to manage different personalities with both confidence and empathy
Experience with CRISPR, bacteriophages or antimicrobial resistance is advantageous, but not a requirement

Job Responsibility

Lead and drive the day-to-day progress of two or more research projects within microbiology, bacteriology and synthetic biology
Act as the central hub for project coordination, creating transparency and ensuring clear communication across the team and with adjacent functions such as process development and production
Maintain and continuously revise project plans based on new data, experimental results and changing scientific priorities
Manage shifting timelines, milestones and dependencies in a research environment where uncertainty is part of the work
Identify project blockers early, especially tight deadlines and resource constraints, and escalate or resolve them proactively
Facilitate effective problem-solving among highly specialised scientists and ensure constructive collaboration, particularly under pressure
Apply a mature project management toolbox pragmatically, introducing the right level of structure and process without slowing innovation
Challenge technical assumptions and discussions in a qualified manner by understanding the scientific details well enough to ask the right questions
Ensure a strong flow of information to leadership, including preparation of material and, when relevant, presentations for board meetings and external stakeholders
Help professionalise project leadership practices in the research organisation through leading by doing

Senior Manager Validation

Reporting to the Associate Director of Validation, the Senior Manager of Validat...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Typically 8+ years of experience in management position
Typically 4+ years' experience supervising validation / technical staff
Graduate degree in Science (Microbiology, Cell Biology, Biochemistry an advantage) or Engineering
Significant experience working in a GMP environment within the pharmaceutical/biotechnology industry in the areas of process, plant, equipment, cleaning, analytical methods and computer systems validation
Detailed knowledge of the regulatory requirements across a range of geographies but particularly the US, EU, Canada, Australia and Japan
Substantial experience within the biotechnology sector, with prior experience in the areas of sterile liquid filling, packaging and labelling an advantage

Job Responsibility

Lead in the development of Validation’s vision, mission, strategies, goals and objectives
Maintain, implement and continuously develop a Validation strategy
Responsible for providing Validation expertise in area of equipment sterility, aseptic processing simulation (or media fill) and temperature mapping
Manage the qualification/validation of production equipment, utilities and systems directly associated with sterility of equipment and processes
Provide support for Tech Transfers (NPIs and LCMs) and regulatory submissions
Oversee the preparation, execution, documentation and reporting of validation studies
Responsible for the development, revision, review, and approval of Standard Operating Procedures
Strong people and project management skills with proven ability to define and execute the validation elements of a projects from design to routine facility operation
Capable of creating a team environment among existing site groups and creating a unified culture within the validation organization
Assure the appropriate level of training is undertaken for all levels of the validation organization

Fulltime

Senior Pharma Sales Manager

This role will be for the CAPEX sale of COMECER's Aseptic Fill/Finish (AFF) and ...

Location

United States , Indianapolis

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Bachelor's degree or post-secondary education in engineering, microbiology, or business
Adaptable to different situations, with proven experience in the field of commercialization of Laboratory Equipment, Laboratory Consumables, Aseptic Environments, Lab ware or similar issues with particular reference to aseptic Pharma and Cell & Gene Therapy applications, who can take care of proposing Comecer solutions to North American customers
Demonstrated knowledge of sales and marketing techniques and financial principles
Demonstrated effective negotiation skills, representing the company's long-term business requirements on multi-year contracts
Demonstrated ability to manage multiple tasks and communicate strategically to develop account strategies and project-specific win strategies
Fluent in English, written and oral, fluent in Italian is an asset
Technical proficiency / capability for using Sales Force, Microsoft Office tools
Effective verbal and written communication and presentation skills
Must be eligible and able to travel domestically & internationally within 30 days from hire date and legally eligible to operate a vehicle, as this is an essential job function.

Job Responsibility

Sales and Business Development Strategy
The Sales Manager will be responsible for revenues of the Key Accounts and territory assigned to their care
Collaborate with their director in defining budget forecasts for the assigned territory
Organize activities for customer scouting and recruiting, either through public marketing activities (conferences, meetings, publications, social posts), as well as direct customer contacts, dedicated presentations (direct or via WEB), networking activities and other initiative's
The Sales Manager will be responsible to plan, coordinate and realize, in collaboration with the Head of Global Sales and the VP of Sales & Marketing for the launch in the market of new solutions for the Pharma and Cell & Gene Therapy fields independently developed by the Comecer as well as to suggest possible improvements according to market feedback
Prepare Pharma and Cell & Gene Therapy quotations with Comecer systems (e.g., Sales Force, Fusion, Word, Excel)
Travel will be required
Occasional overtime is expected
Other duties as required
Customer Relationship Management

Fulltime

New

Food Safety and Quality Auditor-Sr. leader

The Food Safety and Quality Sr. Leaders role is part of the PFNA Corporate Quali...

Location

United States , Plano

Salary:

80200.00 - 134250.00 USD / Year

Pepsico

Expiration Date

Until further notice

Requirements

Bachelor's degree required in Chemistry, Food Science, Microbiology, Engineering or related field
Quality and Food Safety background preferably in field manufacturing for at least 5 years, with strong understanding of food safety regulatory requirements and core PFNA quality and food safety programs
Able to travel 50 to 60% and support the PFNA Network (USA, Canada, and Mexico)
must have a valid passport
Authorized to work in the US, and able to obtain a Canadian work permit as needed
Must be PCQI trained or able to successfully complete PCQI training
Understanding of applicable food regulations: FSMA, cGMP, HACCP, Food Safety Standards in accordance with FDA, USDA, CFIA, etc.
Strong systematic problem-solving skills and demonstrated aptitude for structured root cause analysis with demonstrated ability to identify critical data, develop corrective actions, and drive issue resolution
Strong written and verbal communication skills with ability to influence at all levels, including senior leadership
Agile, self-starter with the ability to work with independently in scheduling, planning and managing competing priorities in a fast-paced environment

Job Responsibility

Lead the monitoring and verification of compliance to the PFNA Quality and Food Safety Policies and Standards across internal and contract manufacturing facilities through effective execution of QAS Audits, ensuring consistency and calibrated assessment
Lead close-out discussions with the site
Establish and maintain effective communication with plants assigned for auditing and manage schedule to ensure robust and efficient completion of these audits
Evaluate trends, identify systematic gaps and recurring themes across the QFS Management Systems to proactively develop and implement strategies to strengthen processes and overall performance across all PFNA facilities
Prepare, distribute management reports for the audits and specific program details, and share updates on corrective action progress and strategies to leadership
National ownership and SME of assigned Quality and Food Safety Management Systems and strategic point assignments
effectively collaborate with cross-functional teams across the HQ QFS, R&D, MCOE, and the field teams to develop or enhance PFNA standardization of policies, protocols, procedures, work instructions, job-aids, training content, etc. for these systems
Support training, education and capability-building initiatives that strengthen quality and food safety performance and culture across PFNA
Provide leadership in systematic problem solving and project management to address QFS issues
develop and drive sustainable improvement strategies and deliver effective change management

What we offer

Bonus based on performance and eligibility target payout is 8% of annual salary paid out annually
Paid time off subject to eligibility, including paid parental leave, vacation, sick, and bereavement
Medical, Dental, Vision, Disability, Health, and Dependent Care Reimbursement Accounts
Employee Assistance Program (EAP)
Insurance (Accident, Group Legal, Life)
Defined Contribution Retirement Plan

Fulltime

New

Manager Quality Control (Micro and Sample Management)

Manager Quality Control (Micro and Sample Management) at Amgen Singapore Manufac...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of Quality or Operations related experience
OR Bachelor's degree and 4 years of Quality or Operations related experience
OR Diploma and 8 years of directly related experience
Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
Ability to lead diverse teams
Good communication skills (technical writing and verbal communication/presentation)
Ability to work in cross-functional and multisite teams

Job Responsibility

Lead and supervise QC Microbiology Shift teams
Maintain the weekly lab schedule and prioritize daily work tasks
Provide Quality oversight to ensure processes follow cGMP
Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP
Perform review, approval and tracking of cGMP processes, procedures, documents and records including nonconformance records and CAPAs
Oversee day to day activities in microbiology (routine environmental & utilities monitoring
raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID
media, reagent and culture qualification such as growth promotion
etc.)
Oversee sample management and stability (sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.)

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Regulatory Compliance Manager

The Regulatory Compliance Manager oversees the product-related regulatory compli...

Location

United States , Malvern

Salary:

10000.00 - 13000.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor's degree in scientific discipline such as Chemistry, Biology, Microbiology, Physics, Quality, or Environmental Science
At least 5-8 years of experience with regulations, SOPs, compliance, and/or quality management in pharmaceutical, biotech, medical, medical product, hygiene, cleanroom engineering/products manufacturing, or other regulated chemical industry
Knowledgeable in domestic and international chemicals
Communicates clearly, professionally and concisely, both verbally and in writing
Proficiency with Microsoft Word, Excel, and PowerPoint are required
Exceptional attention to detail and organizational skills
Ability to manage multiple projects and competing priorities

Job Responsibility

Serves as a subject matter expert for chemical, disinfectant, and antimicrobial products
Develops and implements global regulatory strategies to support product commercialization, lifecycle management, and market expansion
Reviews and monitors regulations with respect to global activities
Prepares summaries of new and changing regulatory requirements and communicates potential impacts as necessary to senior management
Provides regulatory input during product development, formulation changes, and manufacturing changes to assess regulatory impact and approval requirements
Coordinates product registration at domestic and international levels
Prepares regulatory submissions prior to agency filing
Domestic regulatory activities, including EPA and FDA annual volume reporting, as well as product and establishment renewal activities, and US State registrations and renewals
Responds to regulatory agency inquiries connected to registrations, notifications and changes
Participates in audits and inspections performed by regulatory agencies and prepares supporting and briefing documents as necessary

Fulltime

Validation Manager

The validation department performs sterilisation validation activities to ensure...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with 5+ years of experience in Validation, Engineering
BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality

Job Responsibility

Provide leadership and guidance to the validation team, with clear goals and expectations for the day-to-day activities for Validation, Re-Qualification and Periodic Review programs
Support Operations from a Validation perspective to deliver and maintain equipment in a qualified state in the most efficient manner possible
Develop and ensure internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans specific to area of responsibility
Responsible for managing and co-ordinating the aseptic process simulation program, including aseptic intervention review, protocol and summary report review, MES hold time support
Collate and report on relevant validation data and metrics
Provide validation support for Amgen’s quality management system, including change control, deviation and CAPA processes
Participate and deliver regulatory filings and RTQ’s for validation
Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process
Work on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors
Writes and/or implements, owns and approves changes to controlled documents (e.g., SOPs, Specifications, Master Protocols, etc.) as needed

Senior Qc Engineer

The Senior QC Engineer is responsible for the QC aspects of the KC project. He/S...

Location

China , Tonglu

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Bachelor's degree or above in Biology, Pharmaceutical Sciences, Chemistry, Testing & Inspection, or related fields
Hands-on experience or solid knowledge of physicochemical, microbiological, and endotoxin testing
Familiarity with GMP and laboratory quality standards is preferred
Strong sense of responsibility, attention to detail, and quality awareness
Good communication skills and ability to work effectively in a team
Proficiency in written and spoken English
able to read, understand, and prepare technical documents and SOPs in English
Willing and able to stay at the Sweden site for 2–4 weeks to support project needs

Job Responsibility

Perform testing and release of experimental samples, finished products, and raw materials
Conduct routine physicochemical testing, microbiological limit testing, and endotoxin testing in accordance with approved procedures
Accurately record, review, and report test results, ensuring data integrity and traceability
Support the maintenance of the laboratory quality management system, including participation in deviation, OOS, and change control activities
Operate, maintain, and document the use of laboratory instruments and equipment
Assist with internal and external audits and inspections as required

Fulltime

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Senior Microbiology/ Project Manager

Job Description

Job Responsibility

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What we offer

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