Oligo Manufacturing Lead - Swing shift

LGC; Petaluma (CA); On-site; USD 29,000 - 48,000; Full time

Benefits offered by this job

Competitive compensation with bonus

Medical, dental, and vision benefits

FSA/HSA pre-tax plans

401(k) retirement plan

Flexible work options

Pet Insurance

8 weeks of parental leave

PTO

Town Hall and social events

Job summary

LGC Biosearch Technologies seeks a GMP Manufacturing Lead in Petaluma, CA to ensure department functions comply with company procedures and external regulations. You will work with Supervisors and Managers to guarantee quality and regulatory adherence in the GMP Manufacturing Lab.

The role requires a bachelor’s degree or equivalent GMP experience, knowledge of ISO 13485, and strong documentation skills. Training, SOP adherence, and safe lab practices are essential.

Qualifications

• Education: bachelor’s degree or 2+ years of equivalent GMP experience.
• Some instrumentation: e.g., HPLC, MS, Purifiers, Spectramax, SpeedVacs, liquid handlers.
• Math: ability to work with fractions, decimals and various units.
• Computer: MS Office, Outlook, Word, Excel; Unicorn and Empower a plus.

Responsibilities

• Learn ISO 13485 quality system requirements and follow quality contracts.
• Perform GMP oligonucleotide-related tasks per SOPs.
• Operate instruments in the immediate work area.
• Make policy-guided decisions impacting performance objectives.
• Use tracking/reporting systems to drive quality and timely completion.
• Identify equipment/document issues and take corrective action.
• Lead training and ensure SOP adherence.
• Provide technical guidance to team members.
• Assist with creation/review of GMP manufacturing docs.
• Initiate quality system documentation (Deviations, NCRs, etc.).
• Ensure safe handling of hazardous chemicals and PPE compliance.
• Maintain training up to date.

Skills

Bachelor's degree

GMP experience

Instrumentation

MS Office

Detail-oriented

Education

Bachelor's degree in a related field or 2+ years experience

Tools

Unicorn

Empower

Job description

LGC Biosearch Technologies locations Petaluma, CA, as well as our sister site in Denmark, represent a focused, collaborative culture of producing mission-critical genomics components, primarily oligonucleotides and supporting reagents, for our diverse customer base. We believe in Science for a Safer World and have embodied our mission by supporting first responders during the COVID-19 pandemic where our Biosearch Technologies portfolio has been and continues to be enabling millions of PCR tests worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization.

Since the first NGS platforms were commercialized in the early 2000s, we have been working with our customers to support mission critical applications in human healthcare and agrigenomics. By providing innovative, high-quality components such as enzymes, oligonucleotides and magnetic beads as well as specialist kits and services, we enable our customers to harness the power of genetic data on an unprecedented scale.

Our kit and component manufacturing sites are situated across the US (Middleton and Petaluma) and Europe (Berlin and Lystrup) and are underpinned by either ISO 13485 or ISO 9001 compliance. These capabilities support a wide portfolio of off-the-shelf components and kits critical to NGS workflows including magnetic beads, oligos, enzymes, and library prep kits. Additionally, our primary manufacturing capabilities enable customization and bulk (OEM) manufacture of reagents such as key NGS enzymes for high volume applications.

LGC Biosearch Technologies locations Petaluma, CA, as well as our sister site in Denmark, represent a focused, collaborative culture of producing mission-critical genomics components, primarily oligonucleotides and supporting reagents, for our diverse customer base. We believe in Science for a Safer World and have embodied our mission by supporting first responders during the COVID-19 pandemic where our Biosearch Technologies portfolio has been and continues to be enabling millions of PCR tests worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization.

Since the first NGS platforms were commercialized in the early 2000s, we have been working with our customers to support mission critical applications in human healthcare and agrigenomics. By providing innovative, high-quality components such as enzymes, oligonucleotides and magnetic beads as well as specialist kits and services, we enable our customers to harness the power of genetic data on an unprecedented scale.

Our kit and component manufacturing sites are situated across the US (Middleton and Petaluma) and Europe (Berlin and Lystrup) and are underpinned by either ISO 13485 or ISO 9001 compliance. These capabilities support a wide portfolio of off-the-shelf components and kits critical to NGS workflows including magnetic beads, oligos, enzymes, and library prep kits. Additionally, our primary manufacturing capabilities enable customization and bulk (OEM) manufacture of reagents such as key NGS enzymes for high volume applications.

Job Description

Position Summary

The GMP Manufacturing Lead is responsible for working directly with the departmental Supervisor and Manager to ensure that all respective functions of that department in the GMP Manufacturing Lab are performed in compliance with company procedures and external regulatory requirements.

Roles and Responsibilities

• Conscientiously learns requirements of the ISO 13485 quality management system and diligently follows the terms of a quality contract, which describes the relevance and importance of the employee’s work to the achievement of LGC’s quality objectives
• Perform and or support the respective functions and tasks of that department for GMP oligonucleotides according to established procedures.
• Capable of operating and manufacturing product on all instruments in immediate work area.
• Makes decisions – guided by policies and procedures – that impact the group’s ability to meet performance objectives
• Use tracking and reporting systems, drive performance and assure timely completion of product and process quality
• Recognize any issues from the equipment and any affiliated documentations and take appropriate corrective action within scope
• Lead training activities, oversee training and adherence to standard operating procedures (SOPs)
• Provides technical guidance to team members
• Assist with the creation and review or manufacturing procedures and documentation used in the GMP manufacturing lab.
• Initiates and executes quality system documentation, including Deviation and Nonconformance Reports, Customer Notifications, Change Request Records, etc.
• Responsible for the safe use of hazardous chemicals in a manufacturing environment daily and adherence to the company Personal Protection Equipment (PPE) policy
• Maintain training up to date.
• Travel Requirements – no travel required.
• Schedule/Core Hours – are based upon the Production Lab and Shift, these will be detailed below with potential for overtime hours as the workload requires and with manager’s pre-approval.
• Adherence to company Personal Protection Equipment (PPE) policy.

Qualifications

Education/Experience/Licenses/Certifications

Essential:

• Education: This position requires a bachelor's degree in a related field or 2+ years of equivalent industry experience and training and/or demonstration of ability to meet the requirements of a GMP Technician
• Some Instrumentation: e.g., HPLC, MS, Purifiers, Spectramax, SpeedVacs, Liquid Handlers, TFF, Pipettes, experience or knowledge preferred.
• Mathematical Skills: Ability to add, subtract, multiply, and divide all units of measure, using whole numbers, common fractions, and decimals.
• Computer Skills: Microsoft Office, Outlook, Word, and Excel, use of a web browser – Unicorn and Empower a plus.

Competencies & Behaviours:

• Resonates and operates in line with LGC’s core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
• Self-motivated with the ability to work independently as well as on teams
• Professional presence and strong attention to detail is required
• Technical proficiency that enables effective execution of documented procedures
• Demonstrated experience with common computer software packages (Windows, MS Office, etc.)
• Able to multi-task work in a fast-paced environment.
• Attention to detail and a methodical approach to tasks.
• Strong communication and problem-solving abilities are necessary.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical demands are normal for a laboratory environment as defined below.

Additional Information

The typical pay range for this role is:

Minimum: $ 20.910/ Hourly

Maximum: $ 34.855/ Hourly

This range represents the low and high end of the anticipated salary range for the California -based position. The actual base salary will depend on several factors such as: experience, skills, and location.

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• 8 weeks of parental leave for qualifying life events
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!

ABOUT LGC:

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.

OUR VALUES

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

EQUAL OPPORTUNITIES

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website www.lgcgroup.com

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