Plant Engineer / Sr. Plant Engineer, GMP

About IGM Biosciences, Inc.

IGM Biosciences (Nasdaq: IGMS) is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer and autoimmune and inflammatory diseases. The Company's pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites, compared to conventional IgG antibodies with only 2 binding sites. We have created unique IgM antibodies with high selectivity, affinity, and avidity that may redefine what is possible for therapeutic antibody medicines. We believe our proprietary IgM antibody technology platform is particularly well suited for developing T cell engagers and receptor cross-linking agonists. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology, immunology, and inflammation targets. For more information, please visit www.igmbio.com.

IgM Antibodies and Autoimmune and Inflammatory Diseases

Antibody treatments have revolutionized outcomes for patients with autoimmune and inflammatory diseases. We are committed to exploring how our IgM antibody platform's unique structure and binding properties can improve outcomes for patients with these serious conditions.

IgM Antibodies and Oncology

The potential of our IgM antibodies drives our focus on oncology. Leveraging the power of avidity and the strong and durable binding of our IgM antibodies, we are developing new treatment options for cancer patients. Our initial efforts in this field are centered around the broad application of IgM antibodies to activate receptors, triggering the programmed death of cancer cells.

We seek an experienced plant engineer with a mechanical background who will be responsible for the operation, maintenance, and repair of plant utility and manufacturing equipment and overseeing plant engineering vendors and service technicians in a cGMP manufacturing environment. The ideal candidate has strong customer service skills and is outgoing, friendly, collaborative, organized, and adept at all forms of communication. This position involves collaborating with group leaders and third-party vendors to schedule repairs as needed, ensuring all facility procedures are cGMP compliant at the site. The ideal candidate must have successful interactions with all they encounter.

Responsibilities:

• Responsible for mechanical service calls and in-house repairs throughout the facility. Performs work within multiple maintenance trades, i.e., carpentry/painting, electrical, plumbing, and mechanical repair.

• Monitors current processes and recommends PE equipment and best practices that can lead to more efficient processes.

• Performs routine equipment/system repair, lab/office repair/renovation, system/equipment installation, and system/equipment preventive maintenance/sanitization

• Implements periodic or special inspections of facility equipment/systems to determine repair work necessary and to confirm system/equipment operation is within specified parameters

• As needed, may be responsible for performing maintenance and repair work on process equipment such as autoclaves, incubators, and cold storage equipment.

• Required to perform troubleshooting and diagnostic analysis on utility and process equipment.

• Organize, schedule, and oversee work performed by Outside Service Providers, ensuring good documentation practices and that training requirements are met.

• Assist Plant Engineering Management with daily objectives and, when necessary, carry out supervisory responsibilities following the organization's policies and applicable laws.

• Coordinates Plant Engineering requirements with other functions (e.g., manufacturing, quality).

• Ensure building and grounds are orderly, and all maintenance activities are conducted safely and controlled.

• Support Regulatory, Safety Compliance, Preventive Maintenance, and Calibration Programs.

• Works with PE, Manufacturing, and Quality to resolve deviations.

• Maintain a positive customer-driven level of cooperation and support.

• Represents Plant Engineering in meetings.

• Completes special projects as requested and performs other duties as assigned.

• Must be able to commute to Mountain View.

Qualifications:

• Level commensurate with experience.

• Certificate of Completion at a 2-year technical trade school or, High School diploma with experience in maintenance trades working in Pharma, Biotech or other highly regulated industry, Journeyman.

• Appropriate plumbing, HVAC, electrical, and mechanical Licenses (EPA Refrigerant Recovery Type I, II, III or Universal Certification or Stationary Engineer Level II or III as required) and equivalent work experience to ensure working knowledge.

• 5-7 years of hands-on plant engineering maintenance experience in a GMP-regulated environment is required, with a minimum of 3 years of experience required to oversee contract service personnel.

• Must possess extensive knowledge of specialized functions. A wide and comprehensive acquaintance with and understanding of both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered.

• Must have a working knowledge of cGMP, SOPs, HVAC, refrigeration, Specialty Water Systems, electrical, Gas Delivery Systems, pumps & drives, and chemical treatment equipment operation and maintenance.

• Must be capable of performing work in the mechanical, pipefitting, plumbing, electrical, and instrumentation trades.

• Must be able to work (troubleshoot/perform repairs) in a cleanroom environment.

• Must possess the ability to resolve complex problems/equipment inefficiencies.

• Must be well-versed in using basic hand tools, power tools, and precision measurement instruments.

• Must be able to read and interpret documents such as safety rules, operating and maintenance instructions, Standard Operating Procedures, and P&IDs.

• Must be able to communicate both orally and written clearly and concisely to effectively and positively interact with all levels of staff and management across the organization to complete projects efficiently.

• Candidate must possess computer skills, be detail-oriented, and be able to complete any required documentation (GxP) promptly, including logbooks and work orders.

• Experienced in drafting Plant Engineering-specific SOPs along with proper documentation required for calibration and PM of equipment a plus.

• Good understanding of the Change Control process for validated GMP setting.

• Good understanding of Document Control and upkeep of Plant Engineering documents/drawings.

• Work independently, with minimal supervision, and demonstrate initiative.

• Ability and willingness to work flexible hours as needed, including early mornings, late evenings, holidays, weekends, overtime as needed, and support after-hours On-Call duties.

$124,000 - $141,000 a year

This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location.

Actual individual pay is determined by demonstrated experience and internal equity alignment.

We offer a fast-paced, collaborative, team-based, work environment.

One of our top priorities is to maintain the health and well-being of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:

• Medical, dental and vision insurance.

o The full premium amount for our employees and their dependents is covered by IGM

o FSA (Flexible Spending Account) or HSA (Health Savings Account)

• STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance

o Voluntary Life Insurance and Disability

• 401(k) Plan with Employer Match

• 3 Weeks of Paid Time Off, 5 sick days per year, 12 holidays

• Cell phone & internet subsidy

• Employee Referral Bonus Program

• Annual training budget for professional development

• Commuter Benefit

• Annual bonus program

• New hire stock

o Annual refresh grants

• ESPP (Employee Stock Purchase Plan)

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.