Process Development & Manufacturing – Manufacturing /
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 are searching for a seasoned plant engineering professional who will be responsible for the operation, maintenance, and repair of plant utility and manufacturing equipment and collaborate with plant engineering vendors and service technicians in a cGMP manufacturing environment. For consideration, you must have strong customer service skills, an outgoing and friendly demeanor, and a collaborative spirit. This role involves regular interaction with group leaders at the site and visiting vendors.
If you are a versatile individual with a solid mechanical background and excellent communication skills, please apply. We would love to meet you. In this role, you will support daily manufacturing operations, including scheduling repairs as needed and ensuring facility procedures comply with cGMP regulations.
Responsibilities:
Responds to mechanical service calls and in-house repairs throughout the facility.
Performs work within multiple maintenance trades, including but not limited to carpentry, painting, electrical, plumbing, and mechanical repairs.
Performs routine equipment, system repair, lab, office repair, or renovation, system and equipment installation, and system and equipment preventive maintenance and 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
May be responsible for performing maintenance and repair work on process equipment such as autoclaves, incubators, and cold storage equipment.
Performs troubleshooting and diagnostic analysis on utility and process equipment.
Organizes, schedules, and oversees work performed by external service providers, ensuring good documentation practices and meeting training requirements.
Assists Plant Engineering Leadership in completing daily objectives and, when necessary, carries out supervisory responsibilities, following the organization's policies and applicable laws.
Collaborates with others to plan, modify/schedule repairs and maintenance activities for facilities.
Ensures building and grounds are orderly and all maintenance activities are conducted safely and controlled.
Supports Regulatory, Safety Compliance, Preventive Maintenance, and Calibration Programs.
Maintains a positive customer-driven level of cooperation and support.
Must be able to commute to Mountain View.
Qualifications:
Certificate of Completion at a 2-year technical trade school or a high school diploma with experience in maintenance trades working in Pharma, Biotech, or other highly regulated industries, 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.
A minimum of 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 overseeing contract service personnel.
Must possess extensive knowledge of specialized trades functions, with a comprehensive acquaintance with and understanding of the job's general and specific aspects and their practical application to complex problems and situations ordinarily encountered.
The candidate must have a working knowledge of cGMP, SOPs, HVAC, refrigeration, Specialty Water Systems, electrical, Gas Delivery Systems, pumps and 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 be well-versed in using essential 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 communicate clearly and concisely, both orally and in writing, to effectively and positively interact with all levels of staff and management across the organization.
The candidate must possess computer skills, be detail-oriented, and be able to complete any required documentation (GxP) promptly, including logbooks and work orders.
Experience drafting Plant Engineering-specific SOPs and the proper documentation required for calibration and PM of equipment is 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, including early mornings, late evenings, holidays, weekends, overtime as needed, and support after-hours On-Call duties.
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 and family-like work environment.
One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we offer comprehensive benefits with a variety of options:
· Medical, dental and vision insurance.
· The full premium amount for our employees and their dependents is covered by IGM
· STD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance
· 120 hours of Paid Time Off, 5 sick days per year, 11 holidays
· Cell phone & internet subsidy
· Employee Referral Bonus Program
· Commuter Benefit
· Annual bonus program
· New hire stock options
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.
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