4 Jobs in Kinsale
Associate - QA API EM
Posted today
Job Viewed
Job Description
**Organization Overview:**
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing organizations (CMs). The QA for QC position is essential for ensuring that all QC testing is in accordance with the validated methods and are compliant to cGMPs and regulatory commitments.
**Key Objectives/Deliverables:**
+ Serve as a liaison between CMs and Lilly.
+ Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.
+ Provide quality oversight of CM method validation or method transfer activities
+ Escalate quality issues at CMs to Lilly QA management.
+ Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
+ Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
+ Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.
+ Participate in regulatory inspection preparations with CMs.
+ Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
+ Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.
+ Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
+ Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
+ Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.
+ Participate in APR activities.
+ Participate in projects to improve productivity.
+ Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
**Basic Requirements:**
+ BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
+ 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.
+ **Additional Preferences:**
+ Large molecule testing experience
+ Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
+ Knowledge of pharmaceutical manufacturing operations.
+ Demonstrated coaching and mentoring skills.
+ Experience in root cause analysis.
+ Demonstrated application of statistical skills.
+ Demonstrated strong written and verbal communications skills.
+ Strong attention to detail.
+ Proficiency with computer system applications.
+ Excellent interpersonal skills and networking skills.
+ Ability to organize and prioritize multiple tasks.
+ Ability to influence diverse groups and manage relationships.
**Education Requirements:**
+ BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
**Other Information:**
+ Must complete required training for API EM Quality Assurance.
+ No certifications required.
+ Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
+ Must be able to support 24 hour/day operations.
+ Up to 20% travel US & OUS.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Oligonucleotide Advisor - TSMS External Mfg
Posted 1 day ago
Job Viewed
Job Description
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. The API EM TS/MS Advisor will provide technical and scientific expertise within a dynamic external manufacturing environment. The Advisor is responsible for ensuring delivery of commercialization efforts including technical transfers, process validations, and process optimization for the oligonucleotide portfolio. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions.
**Key Objectives/Deliverables:**
+ Provide technical oversight and stewardship for oligonucleotide manufacturing processes, including synthetic processing steps and downstream purification.
+ Leads resolution of technical issues including those related to control strategy and manufacturing.
+ Employ excellent communication skills to manage internal and external relationships.
+ Build and maintain relationships with development and central technical organizations to influence process control strategies.
+ Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
+ Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
+ Optimize and execute site control strategies.
+ Successfully deliver on strategic initiatives.
+ Authors and provides guidance on Regulatory Submissions, IRs, and changes.
+ Influence and implement the network technical agenda and drive continuous improvement.
+ Maintaining processes in a state of compliance with US and global regulations
+ Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
+ Understand the chemistry and stability of biomolecules.
+ Operate with 'Team Lilly' in mind - including coaching and mentoring of peers and other scientists.
**Basic Requirements:**
+ Ph.D. in scientific disciplines of Biochemistry, Chemistry, Chemical Engineering, Pharmacology, or related fields, or equivalent industry experience (8 years +).
+ Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
**Additional Information**
+ Occasional travel required 5 - 15%.
**LOCATION:**
+ Indianapolis, IN or Kinsale, Ireland
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$123,750 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Principal Scientist, TSMS Cleaning Validation - ADN RAMP Team
Posted 2 days ago
Job Viewed
Job Description
**Organization Overview**
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
**Position Brand Description:**
The Lilly API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.
The ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly's vision of serving more patients.
Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration - and development of the local technical and operational teams to be ready for full operation.
The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director.
**Key Objectives/Deliverables** **:**
Responsible for the development, implementation and establishing ongoing monitoring of the Cleaning Program for new site facilities including but not limited to:
+ Support new site TSMS cleaning teams on developing Cleaning Validation Master Plan for the facility, using expertise and benchmarking from other sites.
+ Develop a standard and clear procedure for conducting a Cleaning Assessment and train relevant personnel on how to implement and maintain.
+ Standardize Cleaning procedures and operating instructions - ensure critical information is present and critical operating parameters for effective cleaning are integrated into electronic tickets.
+ Standardize pre-start safety review for Cleaning and ensure correct involvement of EHS, Engineering and Operations personnel.
+ Ensure cleaning demonstration/validation protocols and reports are standardized and technically correct.
+ Develop appropriate metrics for Cleaning. Support site teams on reporting metrics at Flow Team level.
+ Improve efficiency on cleaning processes and identify projects for improvement (e.g. activities that can run in parallel and those that need to run in sequence).
+ Engage on the development a training program/education for TSMS, Process Engineering, QA and Ops based on the Cleaning Process with site Cleaning team. Work on the roll out of communicating the requirements of each step of the process and ensuring groups have a holistic view of the process.
+ During cleaning execution, provide support to the process teams for cleaning activities ensuring all aspects of the flow are coordinated appropriately. Attend and lead (if required) process team meetings.
+ Coordinate investigations related to cleaning. Trend events across equipment trains and products and drive improvements.
+ Drive improvements in the cleaning program based on external benchmarking / industry trends.
+ Transfer deep understanding of the GQS/Compliance requirements associated with Cleaning.
**Basic** **Requirements:**
+ BSc Chemistry, Biochemistry or related science field with 8-10 years' experiencein pharmaceuticalmanufacturing.
+ MScChemistry, Biochemistryor science-related field with minimum 5 years appropriate industry experience.
**Additional** **Skills/** **Preferences** **:**
+ Deep technical interest and understanding of Cleaning within Small Molecule, Peptide or Biotech.
+ Excellent verbal and written communications skills
+ Strong analytical and problem-solving skills
+ Collaborative skills with operations, process engineering, QCL and other process team members
+ Technical knowledge of cleaningcontrol
+ Ability to coach others
+ Ability to influence without authority
+ Ability to clarify and simplify complex issues
+ Strong trust building with peers and leaders
+ Willing to work off-shift hours as needed to support project milestones and training of new employees
**Other Information:**
The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Project Officer - ACRES Co-operation Project (Lismore, Waterford)
Posted 12 days ago
Job Viewed
Job Description
- Assess habitats and participate in the quality control of habitat assessments submitted by farm advisors
- Produce farm plans
- Participate in the monitoring of key species/habitats and chemical physical parameters as required
- Assist in the assessment of risks to biodiversity, archaeological heritage, and water quality
- Assess fire, flooding, and nest predation risks at a local level
- Assist in the selection and design of landscape actions
- Participate in commonage assessments throughout the country
- Assist the Remote Sensing officer with drone surveys
- Develop engagement with local communities, NGOs and other local stakeholders
- Provide support to staff, DAFM, NPWS and other stakeholders as directed
- Screen proposed non-productive investments and landscape actions
- Deliver training to farmers, advisors, and other stakeholders
- Wildlife Monitoring
- Nest Protection
- Habitat remediation
- Rewetting
- Wildfire Resilience
- Control of Invasive Species
- Methods of Instruction
- Mountain Safety
- Small Boat Handling
- Level 8 degree in Agriculture, Botany, Ecology, Environmental Science, Hydrology, Zoology or similar
- Full clean driving licence
- Eligible to work in Ireland
- 2 years of relevant experience
- FAS Approval as a Farm Advisor
- Approval as a Pesticide Advisor
- Membership of Chartered Institute of Ecology and Environmental Management (CIEEM)
- Experience in Bat/Bird Monitoring, Hydrology or Environmental Impact Assessment
- GIS especially ArcGIS and QGIS
- Starting salary: €37,000 per year rising to €1,000 on successful completion of year 1.
- Mileage and other allowances
- 00 personal equipment allowance on appointment
- 0 annual replenishment allowance
- 0 sustainability allowance for plug-in hybrid or electric vehicle users
- 24 days annual leave
- Pension scheme with matching employers contribution of up to 4%
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