Downstream Manufacturing Manager

Description

The Downstream Manufacturing Manager is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars. The candidate will be responsible in the purification of 50L to 1000L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents.

Work in a team environment to execute batches and can work independently with minimum supervision. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.

Essential Duties & Responsibilities

• Perform and supervise downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis.
• Provides technical direction in the execution and development of the purification process.
• Uses programs to collect and evaluate operating data to conduct on- line adjustments to products, instruments or equipment.
• Prepare / review all quality management related documents (Deviation / Change control / investigation reports etc.)
• Ensure that engineering and clinical batches are executed in a timely manner.
• Establishes operating equipment specifications and improves manufacturing techniques.
• Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Should follow GMP instructions in the manufacturing area and take the lead to follow environmental health and safety policies.
• Coordinate the conduction of investigations and corrections for issues found during the batch execution process.
• Performs other functions as required or assigned.
• Complies with all company policies and standards. 

Requirements

Education:

• Requires a Bachelor or Master’ degree in chemical, biological or biochemical sciences and a minimum of 8 - 12 years of related experience in the biopharmaceutical industry.
• Previous experience working in GMP and aseptic manufacturing environment.
• Experience working with AKTA Process skids or similar and familiarity of single use manufacturing consumables such as bags, tube sets, columns and process manifolds.
• Possess knowledge to execute engineering and clinical batches; familiar with GMP documentation.

Special Skills:

• Ability to work with other team members and independently - good interpersonal skills.
• Good communication / documentation skills: verbal and written, good computer and organization skills, detail oriented.
• Basic computer skills, including knowledge of Word, Excel and spread sheet.
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification/validation. 

Work Environment & Physical Demands:

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.

Supervisory Responsibility, if any: Yes

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.