Serán BioScience

CDMO offering drug formulation & manufacturing

Quality Control Supervisor - In-Process Control, Day Shift

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBend, OR, USANo salary listed

About the Job

Requirements

A bachelor's degree in chemistry, physics, engineering, or a related scientific discipline is required.
Experience with gas chromatography, high-performance liquid chromatography, total organic carbon analysis, and Fourier-transform infrared analysis is required.
Experience with compendial raw material testing is required.
At least 3 years of experience leading and developing successful teams is required.
At least 5 years of Good Manufacturing Practice (GMP) experience is required.
Strong verbal and written communication skills are required.
Strong interpersonal and leadership skills are required.
Strong organizational skills and attention to detail are required.
Time-management skills and a proven ability to meet deadlines and motivate teams are required.
Strong supervisory and leadership skills are required.
Ability to collaborate and work in cross-functional teams is required.
Strong mathematical, analytical, and problem-solving skills are required.
Ability to prioritize tasks and delegate when appropriate is required.
Ability to work effectively in a fast-paced and sometimes stressful environment is required.
Proficiency with Microsoft Office Suite or related software is required.
Ability to meet in-office attendance requirements is required.
Ability to sit or stand for prolonged periods at a desk and work on a computer is required.
Ability to lift up to 50 pounds at times is required.

Responsibilities

Supervise Laboratory Analysts to meet testing requirements in support of the manufacturing schedule.
Work closely with QC Managers to ensure that policies and procedures are followed as written and revised when necessary.
Work with Operations and Supply Chain Management to ensure timely release of raw material, in-process, and intermediate test data, as well as equipment cleaning verification test data.
Maintain laboratory organization and cleanliness.
Recruit, interview, hire, and train new staff.
Oversee the daily workflow of assigned projects and the team.
Provide timely and constructive performance evaluations.
Adhere to Good Manufacturing Practice laboratory standards.
Maintain laboratory organization, supplies, and cleanliness.
Write, revise, and approve standard operating procedures.
Conduct training activities.
Participate in audits and inspections.
Execute validations, qualifications, and batch records.
Conduct scientific and technical reviews.
Interface with vendors.
Interface with clients as needed.
Develop work plans.
Manage cleaning verification assessments.
Perform other assigned supervisory and job-related duties.

The Quality Control Supervisor for the In-Process Control (IPC) team supervises the Laboratory Analysts to meet testing requirements in support of the manufacturing schedule. This position works closely with QC Managers to ensure that policies and procedures are followed as written, and revised when necessary. The QC Supervisor works closely with Operations and Supply Chain Management to ensure the timely release of Raw Materials, In-Process, Intermediate test data and equipment cleaning verification test data. This position is responsible for maintaining laboratory organization and cleanliness.

Supervisory Responsibilities

Directly supervises Laboratory Analysts
Recruits, interviews, hires, and trains new staff
Oversees the daily workflow of all assigned projects and team
Provides constructive and timely performance evaluations
Perform other supervisory related duties as assigned

Duties and Responsibilities

Adheres to GMP laboratory standards
Maintain organization, supplies, and cleanliness of laboratory
Write, revise, and approve SOPs
Conducts training activities
Participates in audits and inspections
Executes validations, qualifications, and batch records
Conducts scientific/technical reviews
Interfaces with vendors
Interfaces with clients on as-needed basis
Develops work plans
Manages cleaning verification assessments
All other duties as assigned

Required Skills and Abilities

Excellent verbal and written communication skills
Excellent interpersonal and leadership skills
Excellent organizational skills and attention to detail
Excellent time management skills with a proven ability to meet deadlines and motivate teams
Strong supervisory and leadership skills
Demonstrate the ability to collaborate and work in cross-functional teams
Strong math, analytical, and problem-solving skills
Ability to prioritize tasks and to delegate them when appropriate
Ability to function well in a high-paced and at times stressful environment
Proficient with Microsoft Office Suite or related software

Education and Experience

Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline
Experience with GC, HPLC, TOC, and FT-IR Analysis
Experience with compendial raw material testing
At least 3 years of experience leading and developing successful teams
Requires 5 years of GMP experience

Physical Requirements

Prolonged periods of sitting or standing at a desk and working on a computer
Must be able to lift to 50 pounds at times
Must be able to meet in-office attendance requirements

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701

About the Company

Serán BioScience

CDMO offering drug formulation & manufacturing

Serán Bioscience is a contract development and manufacturing organization that helps pharmaceutical companies develop and manufacture drugs. It offers preformulation, formulation and dosage-form development, spray drying and particle engineering, plus cGMP manufacturing and analytical quality control. It relies on flexible, client-tailored services and a broad technical toolkit to support a range of clients from startups to large pharma. Its goal is to enable efficient, compliant drug development and production with rigorous quality standards.

Company size: 51-200
Company stage: Growth Equity (Venture Capital)
Total funding: $200M
Headquarters: Bend, OR
Founded: 2016

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