Manager, Production; Manufacturing

Manager, Production Manufacturing

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

Summary :

The Production; Manufacturing Manager supports the timely manufacturing of parenteral products in an aseptic environment according to Current Good Manufacturing Practice (cGMP). The Manager is responsible for the management of all manufacturing activities during a shift for a sterile filling business unit. Additionally, the manager ensures compliance with all relevant regulations and procedures, maintains current good documentation practices (cGDP) for all activities, and participates in training and continuous improvement initiatives to enhance production processes and efficiency. The manager may manage the following departments : Glass Wash, Aseptic Filling and Capping, and Lyophilization teams; Support Supervisor (Compounding and Equipment Preparation); Equipment Mechanic; Production Control Specialist; and Set-up Mechanic. All activities for a shift are overseen by this position.

Essential Duties and Responsibilities :

Directly responsible for managing and coordinating all activities for assigned shift

Responsible for compiling all shift information and line status data in an accurate and timely fashion and reporting that information to the support groups as well as the oncoming shift management team

Responsible for ensuring and enforcing compliance with cGMPs, site-specific policies, and procedures

Will serve as the representative on shift to all internal support groups and aid the customer service representative with external customers

Responsible for maintaining and reporting the performance of current Key Performance Indicators (KPIs)

Responsible for the professional development and mentoring of direct reports

Responsible for the succession planning and in-depth cross-functional training of all members of the shift

Directly accountable for production schedule adherence and material consumption rates

Responsible for all safety incidents and quality deviations that occur on shift and responsible for the thorough investigation and timely reporting of such

Must become fluent in all functional areas of responsibility. Must share resources with other teams / departments as needed and when available

Effective interpersonal relation skills, while maintaining the adaptability to achieve company goals. Verbally expresses ideas and facts in a clear, logical, concise, and accepted grammatical style

Read / interpret SOPs to ensure compliance

Maintain up to date trainings

Other duties as assigned

Education and Experience :

Associate's degree in Science, Business, Engineering or related field of study with a minimum of eight (8) years' experience in a pharmaceutical manufacturing or relevant industry

Minimum of four (4) years' experience in a leadership role

Bachelor's degree in Science, Business, Engineering or related field of study with a minimum of six (6) years' experience in a pharmaceutical manufacturing or relevant industry, preferred

Supervisory Responsibilities :

Responsible for leading and supporting a team to achieve organizational objectives. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language Skills :

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills :

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability :

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills :

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities :

Leads with integrity and respect

Provides guidance, coaching, and mentorship to team members

Demonstrates business acumen

Fosters a collaborative and positive work environment

Champions change

Coaches and Develops

Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

Demonstrates strong attention to detail

Other Qualifications :

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

Must be able to obtain and maintain gowning certification

Must be able to obtain and maintain media qualification

Must be able to wear a respirator

Physical Demands :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment :

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and / or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection. All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.