Production / General Operative (Pharmaceuticals) Job at Randstad (Swindon)

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General Operative

We are seeking a detail-oriented General Operative to join our fast-paced manufa...

Location

United Kingdom , Swindon

Salary:

13.86 GBP / Hour

Randstad

Expiration Date

Until further notice

Requirements

GCSE Math and English (Grade C or above), or evidence of basic numeracy and literacy
Experience working in a regulated industry (e.g., Pharmaceuticals, Food, Automotive, Make-Up, or Engineering)
Good Manufacturing Practice (GMP) knowledge
Exceptional attention to detail
Ability to stay focused during repetitive tasks
Strong verbal and written English proficiency
Good manual dexterity and physical fitness (able to lift up to 15kg and stand for sustained periods)

Job Responsibility

Acquire and maintain a Bronze License Badge for Production area (Grade C/D) access
Adhere to correct gowning and cleaning procedures
Prepare cleaning materials and perform cleaning regimes according to SOPs
Transfer and handle materials safely into classified production areas
Maintain production stock levels and monitor expiration dates
Clean and maintain equipment to SOPs, cGMP, and pharmaceutical standards
Operate airlocks and assist with loading part washers and autoclaves
Assist with packaging, labelling, and in-process weight checks
Conduct environmental monitoring and complete documentation adhering to Data Integrity principles
Report instances of non-conformance

What we offer

22% shift allowance
Overtime available including weekends

Fulltime

Manufacturing Supervisor II

This is where we make life-saving products. You have deep knowledge of and exper...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors degree in Business, Engineering, related field or equivalent, is required
3 years manufacturing experience and 2 years of Supervisory experience
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and minerals
Demonstrated communication, administrative and strong technical leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment
Solid professional writing skills
Ability to lead multiple priorities in a manufacturing plant setting
Good assessment and troubleshooting skills (mechanical, electrical, and process) with demonstrated and confirmed experience and background
Proven understanding of maintenance systems to include preventive maintenance and CMMS
Ability to understand regulatory and safety guidelines applicable to the medical / pharmaceutical industry and industry in general
Must have experience and knowledge with Lockout / Tagout and other Safety Programs

Job Responsibility

Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations
Supervises the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities
Identify/prioritize/provide resources as appropriate
Interviews, hires, coaches, motivates, develops, recognizes and leads performance of direct reports
Provides regular feedback to all direct reports
Assist in setting performance objectives and development plans and supervise progress
Reviews, approves, and handles documentation for batch and system records
Assists in release of product for distribution
Assists in meeting product release time goals
Identifies, initiates and facilitates continuous improvements, lean manufacturing activities and initiatives, such as 5S, visual management, kaizens

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Fulltime

Senior Technical Operator (A-Shift)

We manufacture and supply reliable, high-quality medicines and vaccines to meet ...

Location

United States , Zebulon

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

High School Diploma or GED
5+ years' experience in Production Operator role
3+ years' experience working at GSK in a Production role
OJT certified in all work centers in packaging or the majority of work centers in manufacturing
Demonstrated performance in all Process Operator job roles

Job Responsibility

Operates, challenges, and cleans equipment, replenishes consumable supplies, and all the duties needed by the business in accordance with cGMPs, Batch Documentation, SOPs, ZSPs and JSAs as required and responsible for independently maintaining inspection readiness of area
Actively participates in monitoring equipment for excessive rejects /stoppages utilizing performance data to escalate any problems occurring in the area that affect product quality, safety and other aspects of line performance
Trained in the GSK Production System standards (i.e. 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste. Participates in performance management defect / stoppage trending, steps 1-6 of problem solving, and performing / maintaining OSW and 5S, CIF actions
Deliver against safety, quality, waste & performance objectives defined by strategy deployment. Identifies and able to implement process improvement for areas or alternative operating methods to increase safety, quality, and equipment efficiency aligned to strategy
Recognized as a subject matter expert on operations / process and provides the first line of defense for equipment troubleshooting. Leads and executes minor repairs on the equipment and completes preventative maintenance. Operators possess considerable knowledge of the job and is reliable and able to plan own daily activities and produce high quality and high quantity work. Participates in validation and engineering trials
Fluent and a trainer in systems /applications required for job performance and to monitor and identify trends (i.e. DELTA, myLearning, FreeWeigh, DISY, Active Plant, IP21, SAP work order transactions etc.)
Works in coordination with other associates, assistants, and/or technicians to carry out daily job responsibilities, including recognizing and leading troubleshooting technical issues and providing information to next supervisory level
Maintains full knowledge of the job and is recognized as a certified OJT trainer for the department and to partner with leads to complete SOP changes. Maintains complete acquaintance with and understanding of the general aspects of the job and the practical applications to problems and situations ordinarily encountered
Demonstrates the ability to conduct equipment set up changeovers and start of batch activities to the designed specifications without start up issues and performs start of batch maintenance activities

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Onsite cafeteria
Onsite gym
Temperature-controlled environment
Licensed onsite Health & Wellness clinic

Fulltime

Associate Director Access & Reimbursement

The Associate Director of Access & Reimbursement is responsible for leading the ...

Location

United States

Salary:

210000.00 - 250000.00 USD / Year

The Muse

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, in Business, Health Policy, or Life Sciences preferred
AAPC coding courses / or equivalent a plus
10+ years of relevant experience in the pharmaceutical healthcare sector
5+ years in the vaccine payer space
Experience in working with US payers
Experience in billing /coding for both buy & bill products (medical) & pharmacy billing PBM (drug benefit) (strongly preferred)
Strong leadership skills and demonstrated ability to lead cross functionally
Deep understanding of Commercial, Medicare, and Medicaid and how it pertains to Influenza vaccine coverage and payment
A proven track record of successful account management and executing national strategies
Demonstrated results in the area of GPO, health system, retail, wholesaler/distributor with vaccine reimbursement vs general Pharma

Job Responsibility

Enact key strategic initiatives to help facilitate CSL Seqirus to achieve / exceed specific sales volume, revenue, and profitability targets
Leads CSL Seqirus interactions with all payers. Fosters and develops multi-level and senior relationships to create a foundation for developing a pathway to effectively communicate CSL Seqirus story
Analyze payer access and reimbursement (medical & drug) landscape for near-term and longer-term objectives. Provide insights on the analysis to create change in the organization. Using pareto mentality develops strategies and tactics to ensure positive change. Develops a customized approach for each payer to most effectively influence change. Reports timely feedback regarding account interactions and next steps
With relationship depth and breadth of customer interaction at various (senior management clinical / financial / operational) levels of the customer's organization, builds and maintains relationships with key individuals to enable market access of CSL Seqirus vaccines, developing a favorable environment for pull-through at the national, regional, and local provider levels. Develops and sponsors key programs which address customer needs and enhances the customer value perception of CSL Seqirus
Convinces internal and external stakeholders about the value of the CSL Seqirus Customer Experience vision
Acts as the voice of the customer with internal stakeholders to build Seqirus' acumen on customer challenges
Develops and executes business solutions at customers that help enhance CSL Seqirus' partnership within CSL Seqirus primary channels
Provides expertise to the organization as an SME in regards to reimbursement at national and regional level and ensures CSL Seqirus products have market access at all National and select Regional health plans and PBMs. Has effective strategies in place when there are coverage issues by being able to connect with key payer decision makers immediately to fix coverage issues
Works with internal and external stakeholders to enhance CSL Seqirus position in the market
Identifies areas of opportunity for CSL Seqirus growth and directs the organization to implement in an efficient manner

What we offer

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability
Long-Term Disability
FSA
HSA
Mental Health Benefits
Adoption Leave

Fulltime

Director, Pharmacovigilance

This is a unique opportunity to join a growing Pharmacovigilance team. This PV e...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV
Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV
Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs
Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments
Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
Experience in the preparation and authoring of pre- and post- aggregate safety reports
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Ability to execute and follow-through to completion and documentation

Job Responsibility

Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s)
Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company
Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs
Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable
Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed
Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings
including coordinating materials, data outputs and presentation, agenda and minutes
Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents
leading cross functional teams to assess safety signals
preparing action and communication plans to mitigate/manage product risks

Fulltime

Supply Center Operator

Location

United States , Shawnee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Three to five years’ experience in the pharmaceutical warehouse industry preferred
Must be able to work from written and oral instructions and position requires a basic working knowledge and understanding of regulations by government agencies affecting the pharmaceutical industry (CFR’s)
Experience safely operating multiple powered industrial truck as well as other material handling equipment.
Must be able to complete required training and certification required by both internal/external agencies.
Must be detailed oriented.
ERP experience (SAP) preferred

Job Responsibility

Work closely with Supply Center Coordinator, to ensure sales orders are accurately picked and staged to meet customers’ requirements.
Work closely with our internal and external customers and suppliers in coordinating in-bound and out-bound freight and associated dock appointments.
Support general warehousing activity requirements, such as but not limited to cycle counts, destruction orders, product labeling etc.
Work closely with Production Material Handlers to ensure raw materials and packaging are pulled accurately and delivered to the specified production areas according to required dates and times.
Utilize experience in supply chain to communicate and implement efficiencies to drive process improvement.
Ensure all training is current to ensure audit compliance (personal).
Ensure supply center is audit ready at all times (cleanliness, organization, etc.)
Ensure all safety training is current to ensure audit compliance.

Fulltime

Manufacturing Supervisor II (12-Hour Days)

This is where we make life-saving products. You have deep knowledge of and exper...

Location

United States , Round Lake

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors degree in Business, Engineering, related field or equivalent, is required
3 years manufacturing experience and 2 years of Supervisory experience
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and minerals
Demonstrated communication, administrative and strong technical leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment
Solid professional writing skills
Ability to lead multiple priorities in a manufacturing plant setting
Good assessment and troubleshooting skills (mechanical, electrical, and process) with demonstrated and confirmed experience and background
Proven understanding of maintenance systems to include preventive maintenance and CMMS
Ability to understand regulatory and safety guidelines applicable to the medical / pharmaceutical industry and industry in general
Must have experience and knowledge with Lockout / Tagout and other Safety Programs

Job Responsibility

Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations
Supervises the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities
Identify/prioritize/provide resources as appropriate
Interviews, hires, coaches, motivates, develops, recognizes and leads performance of direct reports
Provides regular feedback to all direct reports
Assist in setting performance objectives and development plans and supervise progress
Reviews, approves, and handles documentation for batch and system records
Assists in release of product for distribution
Assists in meeting product release time goals
Identifies, initiates and facilitates continuous improvements, lean manufacturing activities and initiatives, such as 5S, visual management, kaizens

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Fulltime

Sr Engineer

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Cambridge

Salary:

134202.00 - 149145.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree (or foreign equivalent) in Pharmaceutical Manufacturing, Pharmaceutical Science, Chemical Engineering or related field and 3 years of experience in the job offered or in an Engineering - related occupation. The position required 3 years of experience in the following: 1. Apply engineering and scientific principles to design and implement wet granulation, roller compaction, blending, milling, drying, compression, encapsulation and coating processes. 2. Process Characterization, Technical Transfer to commercial drug product sites, and Process Validation of oral solid drug products. 3. Project management skills utilizing tools including Microsoft Project
4. Quality and regulatory systems including TrackWise, drug product manufacturing, and process validation
5. Apply problem solving methodologies including fishbone diagrams and 5 whys to RCA investigations. 6. Identify and evaluate critical process parameters including statistical analysis.

Job Responsibility

Act as a drug product technical authority, to provide leadership and solutions when troubleshooting oral solid drug product manufacturing, for all unit operations including but not limited to compression, blending, milling, granulation, drying, compaction and coating
Lead via cross-site teams, and in general by setting the agenda and identifying potential issues
Provide process development expertise for commercial drug product processing in specific areas such process characterization, technology transfer, process validation and routine commercial production
Tackle issues with drug product processing technologies and equipment
Identify and manage implementation of operational improvement opportunities for current and new processes
Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA
and Visit contract manufacturing sites to support key production breakthroughs and establish relationships. Position requires up to 25% of travel to various unanticipated worksites nationally and internationally.

What we offer

stock
retirement
medical
life and disability insurance
eligibility for an annual bonus
Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives

Fulltime

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