Chemistry Manager

Hikma; Bedford (OH); On-site; USD 93,000 - 158,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with company match

PTO 20 days

Personal days

Holidays

Health benefits

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio, is seeking a Manager, Chemistry Operations who will oversee the Chemistry testing laboratory, staff, budget, and compliance with cGMP, USP, and FDA/EU requirements.

The role collaborates with manufacturing and product development to improve quality, drive cost savings, and prepare for audits; requires a chemistry degree with 5+ years and leadership experience.

Qualifications

• Bachelor’s Degree in Chemistry, or biological science with 5+ years’ experience.
• Masters’ Degree in Chemistry, or biological science with 3-6 years’ experience.
• Ph.D. in relevant scientific field with 0-3 years’ experience.

Responsibilities

• Manage method verifications and validation studies in support of compendial changes, regulatory compliance and new product support.
• Review and approve study protocols and reports.
• Manage CPA's and operating budget for the lab.
• Work with teams of business units and meeting operational goals.
• Provide directions to team using Quality Laboratory short-term objectives, general policies and management guidance related to lab operation.
• Ensure compliance with testing SOPs and specifications.
• Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
• Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
• Manage capital and operating budget for the lab.
• Assure compliance with company procedures. Prepare the department ready for an audit by both internal and external authorities.
• Assure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and insure employees have development plans.
• Conduct routine investigation and departmental meetings to facilitate the performance of release function.
• Places lots on HOLD if Quality issues are detected and notify senior management.
• Attend interdepartmental meetings representing Chemistry and makes sound quality decisions.
• Manage attendance records for all direct reports.

Skills

Quality lab operations

Budget management

Supervisory skills

Regulatory knowledge

Documentation skills

Team leadership

Regulatory communication

Education

Bachelor’s degree in Chemistry or biological science

Master’s degree in Chemistry or biological science

Ph.D. in relevant field

Tools

MS Office

Documentation systems

Job description

Job Title

Manager, Chemistry Operations

Location

Bedford, Ohio

Job Type

Full Time

About Us

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Chemistry Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to Chemistry testing of product assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. Assure that any discrepancies are investigated thoroughly and in a timely manner. Responsible for managing people and systems that assure product quality. Ensure that non-compliant situations are thoroughly investigated. Organize, direct and evaluate the routine activities of the Chemistry Laboratory to ensure the safety and reliability of products, and to comply with quality and regulatory requirements. Identify potential risks associated with laboratory operations and lead teams to resolve lab issues.

Key Responsibilities

• Regular and predictable onsite attendance and punctuality.
• Manage method verifications and validation studies in support of compendial changes, regulatory compliance and new product support. Review and approve study protocols and reports.
• Manage CPA's and operating budget for the lab.
• Work with teams of business units and meeting operational goals
• Provide directions to team using Quality Laboratory short-term objectives, general policies and management guidance related to lab operation.
• Ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
• Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
• Manage capital and operating budget for the lab.
• Assure compliance with company procedures. Prepare the department ready for an audit by both internal and external authorities.
• Assure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and insure employees have development plans.
• Conduct routine investigation and departmental meetings to facilitate the performance of release function.
• Places lots on HOLD if Quality issues are detected and notify senior management.
• Attend interdepartmental meetings representing Chemistry and makes sound quality decisions.
• Manage attendance records for all direct reports.

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Minimum: Bachelor’s Degree in Chemistry, or biological science with 5+ years’ experience.
• Masters’ Degree in Chemistry, or biological science with 3-6 years’ experience.
• Ph.D. in relevant scientific field with 0-3 years’ experience.

Skills

• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs very well
• Must have the ability of managing complex projects and resolving complex lab issues
• Must possess excellent supervisory and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.
• Must have history of strong documentation skills and attention to detail.
• Familiarity with cGMPs and CFR for US and EU.
• Excellent organizational skills and ability to multi-task and perform work in a timely manner
• Demonstrates ability to lead a department, projects and meetings effectively
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
• General computer skills and ability to prepare presentations and address large groups
• Demonstrated attention to details and accuracy

Compensation

Base Salary: $92,850 to $158,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Recruiters

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.