Job Description

Explore an outstanding opportunity to join a world-class team at LGC as a Scientist I, Manufacturing. In this role, you will play a crucial part in supporting therapeutic oligonucleotide manufacturing by flawlessly transferring processes from development stages to GMP manufacturing. You will author essential documentation, drive process improvements, and collaborate closely with both internal teams and clients to ensure our manufacturing processes are exceptionally efficient and compliant.

Roles and Responsibilities:

• Move protocols from development labs to GMP manufacturing, ensuring seamless implementation and adherence to scale-up documentation.
• Author critical manufacturing documents, including manufacturing reports, batch records, and risk assessments.
• Implement innovative methods and tools to drive manufacturing growth and process improvements. This includes writing and implementing validation protocols, setting up small equipment, and developing new SOP/WI.
• Provide comprehensive process training to chemists regarding new processes being transferred to the manufacturing suite.
• Lead and support deviation investigations, offering technical support in root cause failure analysis for production and quality incidents.
• Actively participate in internal and client-facing technical discussions and audits to ensure transparency and collaborative problem-solving.
• Support the material supply chain for manufacturing projects to ensure timely execution of campaigns.
• Ensure strict compliance with cGMP, FDA, and other regulatory standards.
• Stay updated with relevant regulatory and pharmacopeia guidelines (FDA/ICH/USP) to ensure compliance in tech transfer activities.

Qualifications

Minimum Qualifications:

• BS with 4+ years or MS with 2+ years of relevant experience in Chemistry, Chemical Engineering, or a related field.
• Familiarity with upstream/downstream processing, analytical methods, and GMP environments.
• Proven experience in process development, process transfer, scale up/down modelling, equipment, and Unicorn software.
• At least 2 years of practical experience working in an organic or bioprocess laboratory.

Preferred Qualifications:

• Hands-on experience in solid phase oligonucleotide synthesis chemistry, anion-exchange, and/or reverse-phase chromatography.

Skills and Abilities:

• Self-motivated with the ability to work independently and within teams.
• Professional presence and outstanding attention to detail are required.
• Demonstrated experience with common computer software packages (Windows, MS Office, etc.).
• Strong communication and problem-solving abilities are necessary.
• Adaptable to fast-paced, dynamic work environments and shifting demands.
• Highly collaborative, team-oriented, and an effective communicator.
• Passion for making a difference in the world and contributing to our ambitious goals.
• Able to work effectively in a matrix organization.

Additional Information

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
• Enhanced Parental leave of 8 additional weeks
• 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!

The typical pay range for this role is:

Minimum: $ 72,660 yearly

Maximum: $ 121,109 yearly

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.

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.

All your information will be kept confidential according to EEO guidelines.

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

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