Continuous Improvement Manager (Biotech)

Job details

Pay

$80,000 - $100,000 a year

Job type

Full-time

Shift and schedule

Extended hours

Monday to Friday

Work setting

In-person

Office

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Retirement plan
• Vision insurance

Full job description

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) with a mission to provide the highest quality materials to niche life science markets worldwide.

Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team.

This position covers a wide range of functions ensuring cost-effective and value-added processes to the operations of differential technical systems and manufacturing processes. Incumbent will be asked to champion operational excellence initiatives and liaise with the Production, QA/QC, Supply Chain, Process Development, Facilities and Quality Engineering Departments to ensure all processes are documented and executed according to established Standard Operating Procedures (SOPs). The ideal candidate possesses a chemical or biological background within an ISO environment and led small groups toward a GMP certification.

If you want to contribute to the growth of this industry, we are the right employer for you.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

• Creates, deploys, and enhances Continuous Improvement initiatives and measures the success of such initiatives.
• Ensures that Environmental, Health and Safety (EHS) and Employee Safety Guidelines (ESG) guidelines are strictly followed.
• Leads projects involving multi-disciplinary teams, implementing actions, and assessing results’ efficacy.
• Develops, implements, monitors, and enhances Key Performance Indicators aligned with company’s goals.
• Analyzes current practices, developing manufacturing process improvements, implementing changes in workflows, structures, and teams to ensure continuous performance.
• Contributes to Process Development and Engineering projects and leads transition into manufacturing process.
• Evaluates new technologies and determines how they can support manufacturing processes.
• Investigates deviations, conducts root cause analysis, extracts data analytics, and implements corrective and preventive action to QA, QC, Production, Supply Chain, Quality Engineering and EHS.
• Initiates, measures, and ensures production activities are performed according to established procedures and other regulatory requirements.
• Champions good manufacturing and documentation practices and reviews for accuracy and completeness according to established timelines.
• Upholds production equipment is maintained and is following preventative maintenance programs and calibration.
• Scrutinizes the correct functionality of the production equipment, including troubleshooting and reporting any deviation or failure of equipment to management. Provides training and coaching to KLS employees.
• Works with QA team to implement the quality policies and goals and draft production-related procedures, as needed.
• Other duties as assigned.

MINIMUM EDUCATION and/or EXPERIENCE:

• Bachelor’s degree in Chemistry, Biochemistry and seven (7) to ten (10) years’ directly related experience or equivalent combination of education and experience.

KNOWLEDGE, SKILLS and/or ABILITIES:

• Working knowledge of production equipment including reactors, agitation, vacuum pumps, and vacuum ovens.
• Ability to work with minimal supervision to prioritize, resolve conflict and achieve results in a fast-paced, high-pressure environment as well as manage changing priorities.
• Advanced analytical and problem-solving skills, with the ability to analyze complex data, identify patterns and make data-driven decisions using the Who, What, When, Where and Why with speed, agility and accuracy.
• Strong written skills to create and establish Standard Operating Procedures (SOP), batch records, and document revisions.
• Advanced analytical and problem-solving skills, with the ability to analyze complex data, identify patterns and make data-driven decisions using the Who, What, When, Where and Why with speed, agility and accuracy.
• Mathematical accuracy and strong ability to prioritize multiple projects to meet hard deadlines.
• Read and comprehend highly complex instructions, correspondence, and electronic emails. Write reports, and effectively present information in one-on-one and small group situations to customers, vendors, and employees across a cross-functional matrix.
• Proficient Microsoft Office Suite skills: Word, Excel, PowerPoint, Outlook, and enterprise resource planning (ERP) software such as JD Edwards; working knowledge of Project Management using MS Project software.
• Strong organizational skills with attention to detail, high-level of accuracy and strong follow-through.

PHYSICAL DEMANDS and/or WORK ENVIRONMENT:

(Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Works in a typical office environment with prolonged periods in front a computer entering or researching data.
• Ability to lift to 50 pounds with assistance.
• Regularly required to sit; use hands to finger, handle or feel and talk or hear.
• Availability and willingness to travel if required as part of supplier management or if requested to visit or attend a business transaction as legal agent of the company.
• Must be able to work extended hours per the demands of the business.

The above statements are intended to describe, in broad terms, the general functions and responsibility levels and characteristics of positions assigned to this classification. They should not be viewed as an all-inclusive list of duties and responsibilities. Management has the right to change duties at any time to meet business needs.

Compensation/Benefits:

KLS offers a competitive compensation and benefits package. We believe diversity is key to our competitive advantage and value the diversity among our employees. We are proud to be an EEO employer

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